Acnevir Gel
- Manufacturer
- Denison Pharmaceuticals, LLC
- Effective date
- 2018-12-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:34:08
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients.........................Purpose
Rescorcinol 2x................................Acne treatment
Salicylic Acid 3x..............................Acne treatment
Sulphur 1x......................................Acne treatment
OTC - PURPOSE SECTION
Purpose
Acne treatment
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
INDICATIONS & USAGE SECTION
Uses
For the treatment of acne, redness and other eruptions of the skin.
WARNINGS SECTION
Warnings
For external use only.
Do not use on
- broken skin
- large areas of the skin
When using this product
- avoid contact with the eyes. Rinse right away with water if it gets in eyes.
- apply only to areas with acne
- skin irritations and dryness are more likely to occur if you use another topical acne medication at the time. If irritation occurs, use only one topical acne medication at a time.
Stop use and ask a doctor if
- skin irritation occurs or gets worse.
DOSAGE & ADMINISTRATION SECTION
Directions
- Read all package directions and warnings before use.
- Only only as directed.
- Clean skin thoroughly before applying this product.
- Cover the entire affected area with a thin layer of Acnevir Gel one to three times a daily.
- Massage gently until absorbed into the skin.
- Because of excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- Intended for use by normally healthy individuals only.
- Persons under 18 years of age or those with sensitive of allergic skin should consult a doctor prior to use.
- Sensitivity Test for a New User. Apply product sparingly to one or two affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
INACTIVE INGREDIENT SECTION
Inactive ingredients
Acrylate, aloe barbadensis leaf juice, diazolidinyl urea, lactose, methylparaben, propylene glycol, propylparaben, tetrasodium EDTA, triethanolamine, water
OTC - QUESTIONS SECTION
Questions? 1-800-792-2582
OTHER SAFETY INFORMATION
Other information
You may report serious side effects to the phone number provided under Questions? below.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Acnevir
- Resorcinol, Salicylic Acid, Sulphur
- SULFUR
- LACTOSE, UNSPECIFIED FORM
- ANHYDROUS LACTOSE
- EDETATE SODIUM
- EDETIC ACID
- TROLAMINE
- CARBOMER 934
- DIAZOLIDINYL UREA
- METHYLPARABEN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- RESORCINOL
- SALICYLIC ACID
- WATER
- ALOE VERA LEAF
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0295-1080 | 0295-1080-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SULFUR | 70FD1KFU70 | ACTIB |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| EDETATE SODIUM | MP1J8420LU | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| CARBOMER 934 | Z135WT9208 | IACT |
| DIAZOLIDINYL UREA | H5RIZ3MPW4 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| RESORCINOL | YUL4LO94HK | ACTIB |
| SALICYLIC ACID | O414PZ4LPZ | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
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 |
|---|---|---|---|---|---|---|
| cc871ed5-a5c9-d5db-e053-2995a90a62c0 | 7cef7564-6bdc-34a6-e053-2a91aa0ac2b0 | 2021-09-21 | Warnings | 7cef7564-6bdc-34a6-e053-2a91aa0ac2b0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
