benzoyl peroxide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 328 | 94-36-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A peroxide derivative that has been used topically for BURNS and as a dermatologic agent in the treatment of ACNE and POISON IVY DERMATITIS. It is used also as a bleach in the food industry.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 26, 1984 | FDA | VALEANT INTL |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Broncholithiasis | 86.94 | 19.73 | 14 | 2592 | 239 | 63486177 |
| Lymph node calcification | 83.14 | 19.73 | 14 | 2592 | 318 | 63486098 |
| Bronchial wall thickening | 62.08 | 19.73 | 14 | 2592 | 1485 | 63484931 |
| Completed suicide | 46.10 | 19.73 | 42 | 2564 | 145631 | 63340785 |
| Swelling face | 46.06 | 19.73 | 30 | 2576 | 63445 | 63422971 |
| Lichen nitidus | 45.54 | 19.73 | 7 | 2599 | 87 | 63486329 |
| Polyarteritis nodosa | 37.64 | 19.73 | 7 | 2599 | 284 | 63486132 |
| Toxicity to various agents | 37.01 | 19.73 | 48 | 2558 | 247202 | 63239214 |
| Erythema | 34.22 | 19.73 | 39 | 2567 | 175712 | 63310704 |
| Soft tissue necrosis | 27.14 | 19.73 | 6 | 2600 | 581 | 63485835 |
| Eye swelling | 26.92 | 19.73 | 15 | 2591 | 23903 | 63462513 |
| Sexual abuse | 26.51 | 19.73 | 5 | 2601 | 219 | 63486197 |
| Obstructive airways disorder | 26.11 | 19.73 | 14 | 2592 | 20685 | 63465731 |
| Psoriasis | 23.49 | 19.73 | 23 | 2583 | 86934 | 63399482 |
| Cerebral ischaemia | 22.65 | 19.73 | 9 | 2597 | 6719 | 63479697 |
| Embolism | 21.24 | 19.73 | 9 | 2597 | 7897 | 63478519 |
| Bladder discomfort | 20.51 | 19.73 | 5 | 2601 | 742 | 63485674 |
| Application site discolouration | 20.04 | 19.73 | 5 | 2601 | 816 | 63485600 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Choroiditis | 69.47 | 24.60 | 15 | 1545 | 1200 | 34954171 |
| Endophthalmitis | 62.94 | 24.60 | 17 | 1543 | 3491 | 34951880 |
| Completed suicide | 48.84 | 24.60 | 38 | 1522 | 98130 | 34857241 |
| Visual acuity reduced | 47.31 | 24.60 | 20 | 1540 | 16129 | 34939242 |
| Condition aggravated | 43.74 | 24.60 | 48 | 1512 | 192148 | 34763223 |
| Intraocular pressure increased | 43.21 | 24.60 | 14 | 1546 | 5369 | 34950002 |
| Eye pain | 37.19 | 24.60 | 16 | 1544 | 13446 | 34941925 |
| Post inflammatory pigmentation change | 30.72 | 24.60 | 6 | 1554 | 291 | 34955080 |
| Chondritis | 27.47 | 24.60 | 5 | 1555 | 165 | 34955206 |
| Toxicity to various agents | 26.20 | 24.60 | 38 | 1522 | 200324 | 34755047 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Completed suicide | 83.42 | 17.89 | 79 | 3760 | 245688 | 79494861 |
| Broncholithiasis | 78.26 | 17.89 | 13 | 3826 | 229 | 79740320 |
| Lymph node calcification | 71.26 | 17.89 | 13 | 3826 | 402 | 79740147 |
| Choroiditis | 60.99 | 17.89 | 14 | 3825 | 1367 | 79739182 |
| Toxicity to various agents | 56.15 | 17.89 | 84 | 3755 | 421456 | 79319093 |
| Endophthalmitis | 47.47 | 17.89 | 16 | 3823 | 6412 | 79734137 |
| Bronchial wall thickening | 47.31 | 17.89 | 13 | 3826 | 2628 | 79737921 |
| Lichen nitidus | 44.20 | 17.89 | 7 | 3832 | 90 | 79740459 |
| Soft tissue necrosis | 38.93 | 17.89 | 9 | 3830 | 906 | 79739643 |
| Swelling face | 36.44 | 17.89 | 29 | 3810 | 71183 | 79669366 |
| Eye pain | 34.82 | 17.89 | 22 | 3817 | 37556 | 79702993 |
| Erythema | 34.76 | 17.89 | 48 | 3791 | 223242 | 79517307 |
| Psoriasis | 34.55 | 17.89 | 31 | 3808 | 89556 | 79650993 |
| Polyarteritis nodosa | 32.14 | 17.89 | 7 | 3832 | 538 | 79740011 |
| Visual acuity reduced | 31.76 | 17.89 | 19 | 3820 | 29450 | 79711099 |
| Intraocular pressure increased | 31.39 | 17.89 | 13 | 3826 | 9192 | 79731357 |
| Acne | 30.53 | 17.89 | 18 | 3821 | 27172 | 79713377 |
| Post inflammatory pigmentation change | 27.48 | 17.89 | 6 | 3833 | 466 | 79740083 |
| Pneumomediastinum | 26.57 | 17.89 | 9 | 3830 | 3658 | 79736891 |
| Eye swelling | 23.29 | 17.89 | 15 | 3824 | 26453 | 79714096 |
| Dystonia | 21.01 | 17.89 | 13 | 3826 | 21386 | 79719163 |
| Chondritis | 20.90 | 17.89 | 4 | 3835 | 161 | 79740388 |
| Vision blurred | 19.90 | 17.89 | 25 | 3814 | 105873 | 79634676 |
| Bladder discomfort | 19.65 | 17.89 | 5 | 3834 | 751 | 79739798 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | D10AE01 | DERMATOLOGICALS ANTI-ACNE PREPARATIONS ANTI-ACNE PREPARATIONS FOR TOPICAL USE Peroxides |
| ATC | D10AE51 | DERMATOLOGICALS ANTI-ACNE PREPARATIONS ANTI-ACNE PREPARATIONS FOR TOPICAL USE Peroxides |
| MeSH PA | D003879 | Dermatologic Agents |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Atopic dermatitis | indication | 24079001 | DOID:3310 |
| Contact dermatitis | indication | 40275004 | DOID:2773 |
| Seborrheic dermatitis | indication | 50563003 | DOID:8741 |
| Granuloma annulare | indication | 65508009 | DOID:3777 |
| Acne vulgaris | indication | 88616000 | |
| Pruritus ani | indication | 90446007 | |
| Pruritus of genital organs | indication | 267802000 | |
| Eruption of skin | indication | 271807003 | DOID:0050486 |
| Infection of skin AND/OR subcutaneous tissue | contraindication | 19824006 | |
| Crohn's disease | contraindication | 34000006 | |
| Ulcerative colitis | contraindication | 64766004 | DOID:8577 |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Photosensitivity | contraindication | 90128006 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Condyloma acuminatum | contraindication | 240542006 | DOID:11168 |
| Telangiectasia disorder | contraindication | 247479008 | |
| Skin irritation | contraindication | 367466007 | |
| Adrenal cortical hypofunction | contraindication | 386584007 | DOID:10493 |
| Pseudomembranous enterocolitis | contraindication | 397683000 | |
| Atrophoderma | contraindication | 399979006 | |
| Erythroderma | contraindication | 399992009 | |
| Peripheral vascular disease | contraindication | 400047006 | |
| Blister | contraindication | 417237009 | |
| Denuded skin | contraindication | 418242004 | |
| Inflammatory dermatosis | contraindication | 703938007 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.3%;2.5% | EPIDUO FORTE | GALDERMA LABS | N207917 | July 15, 2015 | RX | GEL | TOPICAL | 8703820 | March 12, 2023 | TREATMENT OF ACNE |
| 0.3%;2.5% | EPIDUO FORTE | GALDERMA LABS | N207917 | July 15, 2015 | RX | GEL | TOPICAL | 8729127 | March 12, 2023 | TREATMENT OF ACNE |
| 0.3%;2.5% | EPIDUO FORTE | GALDERMA LABS | N207917 | July 15, 2015 | RX | GEL | TOPICAL | 9381179 | March 12, 2023 | TREATMENT OF ACNE |
| 0.3%;2.5% | EPIDUO FORTE | GALDERMA LABS | N207917 | July 15, 2015 | RX | GEL | TOPICAL | 9387187 | March 12, 2023 | TREATMENT OF ACNE |
| 0.1%;2.5% | EPIDUO | GALDERMA LABS LP | N022320 | Dec. 8, 2008 | RX | GEL | TOPICAL | 7964202 | Sept. 1, 2024 | TREATMENT OF ACNE |
| 0.1%;2.5% | EPIDUO | GALDERMA LABS LP | N022320 | Dec. 8, 2008 | RX | GEL | TOPICAL | 8445543 | July 12, 2027 | TREATMENT OF ACNE |
| 0.1%;2.5% | EPIDUO | GALDERMA LABS LP | N022320 | Dec. 8, 2008 | RX | GEL | TOPICAL | 8071644 | July 18, 2027 | TREATMENT OF ACNE |
| 0.1%;2.5% | EPIDUO | GALDERMA LABS LP | N022320 | Dec. 8, 2008 | RX | GEL | TOPICAL | 8080537 | July 18, 2027 | TREATMENT OF ACNE |
| 0.1%;2.5% | EPIDUO | GALDERMA LABS LP | N022320 | Dec. 8, 2008 | RX | GEL | TOPICAL | 8129362 | July 18, 2027 | TREATMENT OF ACNE |
| 5% | EPSOLAY | GALDERMA LABS LP | N214510 | April 22, 2022 | RX | CREAM | TOPICAL | 9868103 | Aug. 8, 2028 | TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER |
| 3%;0.1% | TWYNEO | GALDERMA LABS LP | N214902 | July 26, 2021 | RX | CREAM | TOPICAL | 9868103 | Aug. 8, 2028 | TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| 2.5%;EQ 1.2% BASE | ACANYA | BAUSCH | N050819 | Oct. 23, 2008 | RX | GEL | TOPICAL | 10220049 | June 3, 2029 | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER |
| 2.5%;EQ 1.2% BASE | ACANYA | BAUSCH | N050819 | Oct. 23, 2008 | RX | GEL | TOPICAL | 10624918 | June 3, 2029 | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER |
| 2.5%;EQ 1.2% BASE | ACANYA | BAUSCH | N050819 | Oct. 23, 2008 | RX | GEL | TOPICAL | 8663699 | June 3, 2029 | TREATMENT OF ACNE |
| 2.5%;EQ 1.2% BASE | ACANYA | BAUSCH | N050819 | Oct. 23, 2008 | RX | GEL | TOPICAL | 8895070 | June 3, 2029 | TREATMENT OF ACNE |
| 3.75%;EQ 1.2% BASE | ONEXTON | BAUSCH | N050819 | Nov. 24, 2014 | RX | GEL | TOPICAL | 10137142 | June 3, 2029 | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER |
| 3.75%;EQ 1.2% BASE | ONEXTON | BAUSCH | N050819 | Nov. 24, 2014 | RX | GEL | TOPICAL | 10220049 | June 3, 2029 | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER |
| 3.75%;EQ 1.2% BASE | ONEXTON | BAUSCH | N050819 | Nov. 24, 2014 | RX | GEL | TOPICAL | 9504704 | June 3, 2029 | TOPICAL TREATMENT OF ACNE VULGARIS |
| 3.75%;EQ 1.2% BASE | ONEXTON | BAUSCH | N050819 | Nov. 24, 2014 | RX | GEL | TOPICAL | 9504704 | June 3, 2029 | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER |
| 3.75%;EQ 1.2% BASE | ONEXTON | BAUSCH | N050819 | Nov. 24, 2014 | RX | GEL | TOPICAL | 9504704 | June 3, 2029 | TREATMENT OF ACNE |
| 3.75%;EQ 1.2% BASE | ONEXTON | BAUSCH | N050819 | Nov. 24, 2014 | RX | GEL | TOPICAL | 9504704 | June 3, 2029 | TREATMENT OF ACNE VULGARIS |
| 3.75%;EQ 1.2% BASE | ONEXTON | BAUSCH | N050819 | Nov. 24, 2014 | RX | GEL | TOPICAL | 9561208 | June 3, 2029 | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER |
| 2.5%;EQ 1.2% BASE | ACANYA | BAUSCH | N050819 | Oct. 23, 2008 | RX | GEL | TOPICAL | 8288434 | Aug. 5, 2029 | TREATMENT OF ACNE |
| 3.75%;EQ 1.2% BASE | ONEXTON | BAUSCH | N050819 | Nov. 24, 2014 | RX | GEL | TOPICAL | 8288434 | Aug. 5, 2029 | TOPICAL TREATMENT OF ACNE VULGARIS |
| 3.75%;EQ 1.2% BASE | ONEXTON | BAUSCH | N050819 | Nov. 24, 2014 | RX | GEL | TOPICAL | 8288434 | Aug. 5, 2029 | TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER |
| 3.75%;EQ 1.2% BASE | ONEXTON | BAUSCH | N050819 | Nov. 24, 2014 | RX | GEL | TOPICAL | 8288434 | Aug. 5, 2029 | TREATMENT OF ACNE |
| 3.75%;EQ 1.2% BASE | ONEXTON | BAUSCH | N050819 | Nov. 24, 2014 | RX | GEL | TOPICAL | 8288434 | Aug. 5, 2029 | TREATMENT OF ACNE VULGARIS |
| 3%;0.1% | TWYNEO | GALDERMA LABS LP | N214902 | July 26, 2021 | RX | CREAM | TOPICAL | 10653899 | Dec. 30, 2030 | TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| 5% | EPSOLAY | GALDERMA LABS LP | N214510 | April 22, 2022 | RX | CREAM | TOPICAL | 9687465 | Nov. 27, 2032 | TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER |
| 3%;0.1% | TWYNEO | GALDERMA LABS LP | N214902 | July 26, 2021 | RX | CREAM | TOPICAL | 10420743 | July 12, 2038 | TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| 5% | EPSOLAY | GALDERMA LABS LP | N214510 | April 22, 2022 | RX | CREAM | TOPICAL | 10933046 | Feb. 19, 2040 | TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 65 YEARS OF AGE AND OLDER |
| 5% | EPSOLAY | GALDERMA LABS LP | N214510 | April 22, 2022 | RX | CREAM | TOPICAL | 10945987 | Feb. 19, 2040 | TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER |
| 5% | EPSOLAY | GALDERMA LABS LP | N214510 | April 22, 2022 | RX | CREAM | TOPICAL | 11541026 | Feb. 19, 2040 | TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER |
| 5% | EPSOLAY | GALDERMA LABS LP | N214510 | April 22, 2022 | RX | CREAM | TOPICAL | 11426378 | Aug. 18, 2040 | TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER |
| 5% | EPSOLAY | GALDERMA LABS LP | N214510 | April 22, 2022 | RX | CREAM | TOPICAL | 11628155 | Dec. 27, 2040 | TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 5%;1.2% | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | ENCUBE | A212433 | April 28, 2021 | RX | GEL | TOPICAL | March 13, 2023 | COMPETITIVE GENERIC THERAPY |
| 3%;0.1% | TWYNEO | GALDERMA LABS LP | N214902 | July 26, 2021 | RX | CREAM | TOPICAL | July 26, 2024 | NEW COMBINATION |
| 5% | EPSOLAY | GALDERMA LABS LP | N214510 | April 22, 2022 | RX | CREAM | TOPICAL | April 22, 2025 | NEW PRODUCT |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| 4018562 | VUID |
| N0000146882 | NUI |
| D03093 | KEGG_DRUG |
| 1418 | RXNORM |
| C0005088 | UMLSCUI |
| CHEBI:82405 | CHEBI |
| CHEMBL1200370 | ChEMBL_ID |
| DB09096 | DRUGBANK_ID |
| D001585 | MESH_DESCRIPTOR_UI |
| 7187 | PUBCHEM_CID |
| W9WZN9A0GM | UNII |
| 169 | MMSL |
| 4261 | MMSL |
| 354053005 | SNOMEDCT_US |
| 91598004 | SNOMEDCT_US |
| 4018562 | VANDF |
| 001955 | NDDF |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| adapalene and benzoyl peroxide | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0093-6303 | GEL | 25 mg | TOPICAL | NDA authorized generic | 25 sections |
| adapalene and benzoyl peroxide | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0093-6303 | GEL | 25 mg | TOPICAL | NDA authorized generic | 25 sections |
| BenzEFoam | HUMAN OTC DRUG LABEL | 1 | 0187-0194 | AEROSOL | 5.30 g | TOPICAL | OTC monograph final | 11 sections |
| BenzEFoam Ultra | HUMAN OTC DRUG LABEL | 1 | 0187-0201 | AEROSOL | 9.80 g | TOPICAL | OTC monograph final | 11 sections |
| ONEXTON | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0187-3050 | GEL | 37.50 mg | TOPICAL | NDA | 27 sections |
| Benzaclin | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0187-5190 | GEL | 50 mg | TOPICAL | NDA | 21 sections |
| Benzaclin | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0187-5190 | GEL | 50 mg | TOPICAL | NDA | 21 sections |
| Zapzyt Acne | HUMAN OTC DRUG LABEL | 1 | 0295-0010 | GEL | 10 g | TOPICAL | OTC monograph final | 9 sections |
| Cetaphil Gentle Clear BPO Acne Cleanser | HUMAN OTC DRUG LABEL | 1 | 0299-4125 | CREAM | 2.60 g | TOPICAL | OTC monograph final | 9 sections |
| Cetaphil Gentle Clear BPO Acne Cleanser | HUMAN OTC DRUG LABEL | 1 | 0299-4125 | CREAM | 2.60 g | TOPICAL | OTC monograph final | 9 sections |
| Differin Max Strength Acne Foaming BPO Cleanser | HUMAN OTC DRUG LABEL | 1 | 0299-4137 | SOLUTION | 10 g | TOPICAL | OTC monograph final | 9 sections |
| Differin Daily Deep Cleanser with BPO | HUMAN OTC DRUG LABEL | 1 | 0299-4606 | SOLUTION | 5 g | TOPICAL | OTC monograph final | 9 sections |
| Differin Daily Deep Cleanser with BPO | HUMAN OTC DRUG LABEL | 1 | 0299-4606 | SOLUTION | 5 g | TOPICAL | OTC monograph final | 9 sections |
| Differin Daily Deep Cleanser with BPO | HUMAN OTC DRUG LABEL | 1 | 0299-4606 | SOLUTION | 5 g | TOPICAL | OTC monograph final | 9 sections |
| EPSOLAY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0299-5890 | CREAM | 50 mg | TOPICAL | NDA | 26 sections |
| EPSOLAY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0299-5890 | CREAM | 50 mg | TOPICAL | NDA | 26 sections |
| EPSOLAY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0299-5890 | CREAM | 50 mg | TOPICAL | NDA | 26 sections |
| epiduo forte | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0299-5906 | GEL | 25 mg | TOPICAL | NDA | 26 sections |
| epiduo forte | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0299-5906 | GEL | 25 mg | TOPICAL | NDA | 26 sections |
| EPIDUO | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0299-5908 | GEL | 25 mg | TOPICAL | NDA | 24 sections |
| TWYNEO | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0299-5945 | CREAM | 30 mg | TOPICAL | NDA | 26 sections |
| TWYNEO | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0299-5945 | CREAM | 30 mg | TOPICAL | NDA | 26 sections |
| PanOxyl | HUMAN OTC DRUG LABEL | 1 | 0316-0227 | CREAM | 58.70 mg | TOPICAL | OTC monograph final | 14 sections |
| PanOxyl | HUMAN OTC DRUG LABEL | 1 | 0316-0227 | CREAM | 58.70 mg | TOPICAL | OTC monograph final | 14 sections |
| PanOxyl | HUMAN OTC DRUG LABEL | 1 | 0316-0228 | CREAM | 146.70 mg | TOPICAL | OTC monograph final | 14 sections |
| PanOxyl | HUMAN OTC DRUG LABEL | 1 | 0316-0228 | CREAM | 146.70 mg | TOPICAL | OTC monograph final | 14 sections |
| PanOxyl | HUMAN OTC DRUG LABEL | 1 | 0316-0264 | SOAP | 12.60 g | TOPICAL | OTC monograph final | 14 sections |
| Walgreens Acne Spot Treatment | HUMAN OTC DRUG LABEL | 1 | 0363-0116 | LOTION | 25 mg | TOPICAL | OTC monograph final | 12 sections |
| Acne Cleansing Bar | HUMAN OTC DRUG LABEL | 1 | 0363-0137 | SOAP | 100 mg | TOPICAL | OTC monograph final | 13 sections |
| Acne Cleansing Bar | HUMAN OTC DRUG LABEL | 1 | 0363-0137 | SOAP | 100 mg | TOPICAL | OTC monograph final | 13 sections |