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#

ProductAcnevir
Active ingredientSULFUR, RESORCINOL, SALICYLIC ACID
Label structure10 sections

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

labellabel

Products#

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DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-10800295-1080-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cc871ed5-a5c9-d5db-e053-2995a90a62c07cef7564-6bdc-34a6-e053-2a91aa0ac2b02021-09-21WarningsExact identifier
spl set id: 7cef7564-6bdc-34a6-e053-2a91aa0ac2b0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.