Indications and uses
for the treatment and prevention of acne
ACNE THERAPY LOTION
- Manufacturer
- menScience Androceuticals, LLC
- Effective date
- 2023-11-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:00:05
Label at a glance#
ProductACNE THERAPY
Active ingredientBENZOYL PEROXIDE
Label structure6 sections
Dosage and administration
Shake before using. Apply to clean skin. Cover the affected area with a thin layer 1 to 3 times daily. Because too much drying of the skin may occur, start with 1 application daily or every other day, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce applicaction once a day or every other day. If going outside, allow product to ...
Label contents#
Full prescribing information#
Active Ingredient
Benzoyl Peroxide 3%
Purpose
Acne Treatment
Uses
for the treatment and prevention of acne
Warnings
For external use only.
Do not use:
If you have very sensitive skin or sensitive to benzoyl peroxide.
When using this product:
Apply to affected areas only. Avoid unnecessary sun exposure and use a sunscreen. Do not use in or near the eyes, lips or mouth. This product may bleach hair or dyed fabrics. Using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin.
Discontinue use and ask a doctor
if skin irritation becomes severe or if you are using more than one acne medication.
Keep out of reach of children.
If swallowed, get medical help or contact a poison control center right away.
Directions:
Shake before using. Apply to clean skin. Cover the affected area with a thin layer 1 to 3 times daily. Because too much drying of the skin may occur, start with 1 application daily or every other day, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce applicaction once a day or every other day. If going outside, allow product to dry, then use a sunscreen. Store at 20-25 C (68-77 F) o o
Inactive Ingredients
Aqua purificata (purified water), C12-15 Alkyl Benzoate, Urea, Butylene Glycol, Cyclopentasiloxane, Magnesium aluminum silicated, Steareth-20, Peg-100 stearate, Zea mays (corn) starch, Hydroxyethyl acrylate/sodium acryloydimethyl, Taurate copolymer, Squalane, Polysorbate 60, Chamomilla recutita (matricaria) extract, Camellia oleifera leaf extract, Phospholipids, Retinyl palmitate, Tocopherol, Ascorbyl palmitate, Beta-carotene, Ethylhexylglycerin, Cetearyl alcohol, Glycerin, Caprylyl glycol, Dimethicone, Acrylates/C10-30 alkyl acrylate crosspolymer, Steareth-2, Butylene Glycol, Propylene glycol, Panthenol, Disodium EDTA, Allantoin, Phytonadione.
Package Labeling:
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 16a2c1cd-ae95-d910-f03d-7e06b11dd243 | Product name | 5 | 20260202 |
| 653485de-0601-41e4-82db-7a60bb223e27 | Product name | 1 | 20251024 |
| a46239a7-5963-4008-8cbb-6b9000f497eb | Product name | 1 | 20250721 |
| b382b4e1-6b48-45f6-bffc-e61b00b0ce19 | Product name | 3 | 20250317 |
| 23fb3cda-2b50-f3d3-ebde-f542350bd77b | Product name | 4 | 20240828 |
| d9d61457-6a5a-41fc-b418-e5479a2904b7 | Product name | 2 | 20230303 |
| 081b54f0-4545-48b6-b854-03e1401f09ea | Product name | 1 | 20230112 |
| 32012d5c-25ac-49c7-9d4c-1313177fff7c | Product name | 1 | 20230112 |
| 13e7e7e3-e885-4c79-af6d-dad1aedbb06e | Product name | 1 | 20220128 |
| 4a7d44fe-774d-404b-aad0-8a90fe78375a | Product name | 4 | 20211025 |
| 3f45980c-c196-47e5-0e5e-48b7c57327c5 | Product name | 5 | 20200428 |
| d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b | Product name | 3 | 20200203 |
| ee5c6de5-d9cd-454f-b250-7b19e5cf2992 | Product name | 4 | 20190619 |
| aead65a2-216e-4ff8-a178-44aab77c24ed | Product name | 1 | 20180531 |
| ad75fcfd-a339-42a1-9c60-43ba2c654cfa | Product name | 1 | 20170810 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71397-822-55 | ACNE THERAPY | 45 g in 1 BOTTLE | LOTION | 45 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- ACNE THERAPY
- BENZOYL PEROXIDE
- WATER
- ALKYL (C12-15) BENZOATE
- UREA
- BUTYLENE GLYCOL
- CYCLOMETHICONE 5
- MAGNESIUM ALUMINUM SILICATE
- STEARETH-20
- PEG-100 STEARATE
- STARCH, CORN
- HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)
- SQUALANE
- POLYSORBATE 60
- MATRICARIA CHAMOMILLA
- CAMELLIA OLEIFERA LEAF
- LECITHIN, SOYBEAN
- VITAMIN A PALMITATE
- TOCOPHEROL
- ASCORBYL PALMITATE
- .BETA.-CAROTENE
- ETHYLHEXYLGLYCERIN
- CETOSTEARYL ALCOHOL
- GLYCERIN
- CAPRYLYL GLYCOL
- DIMETHICONE
- STEARETH-2
- PROPYLENE GLYCOL
- PANTHENOL
- EDETATE DISODIUM ANHYDROUS
- ALLANTOIN
- PHYTONADIONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71397-822 | 71397-822-55 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ACNE THERAPY | BENZOYL PEROXIDE | menScience Androceuticals, LLC | 4dec259d-200e-44f2-e054-00144ff8d46c | 2023-11-11 | Warnings | 71397-822-55 71397-822 71397082255 09db5d2c-d37b-582f-e063-6294a90ae762 4dec259d-200e-44f2-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.