Adult Acnomel Cream
FDA Label NDC 69846-911

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Numark Brands, Inc for the product Adult Acnomel (NDC 69846-911). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, do not use on:, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active IngredientsPurpose
Resorcinol 2%Acne treatment ointment
Sulfur 8%Acne treatment ointment

Uses

  • for the treatment of acne
  • helps prevent new acne pimples
  • clears up most acne pimples

Warnings

For external use only

Do Not Use On:

  • broken skin
  • large areas of the body

When Using This Product

  • apply only to areas with acne
  • rinse right away with water if it gets in eyes
  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same 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

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because 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

Other Information

  • store at controlled room temperature (59° - 86° F)

Inactive Ingredients

alcohol 15% (w/w), bentonite, carbopol, fragrance, iron oxides, octoxynol-9, potassium hydroxide, propylene glycol, titanium dioxide, water

Principal Display Panel

30% More

ADULT ACNE
Medication

For clear, healthy-looking skin

ADULT ACNOMEL®
Tinted Cream

• Effective treatment for adult acne & blemishes
• Helps improve skin texture affected by Rosacea
• Less drying- does not contain Benzoyl Peroxide

Dermatologist Recommended

• Clears up acne pimples and helps prevent new ones forming
• Helps improve skin texture affected by Rosacea

NET WT. 1.3 OZ.
(36 GRAMS)

Distributed by:
Numark Brands, Inc.
Edison, NJ 08818

G10004
Rev 5/16

Store at controlled room temperature (59° - 86°F)

D1448 Rev 5/16

Distributed by: Numark Brands, Inc. Edison, NJ 08818    1-800-331-0221

30% More

ADULT ACNE
Medication

For clear, healthy-looking skin

ADULT ACNOMEL
Tinted Cream

NET WT. 1.3 OZ. (36 GRAMS)

USES: For the treatment and prevention of Acne Pimples.

WARNINGS: For external use only. Apply only to areas with acne. Do not use on broken skin or apply to large areas of the skin. Rinse right away with water if it gets in the eyes. Stop use and ask a doctor if skin irritation occurs or gets worse. Skin irritation and dryness are more likely to occur if yu use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Keep this and all medication out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

DIRECTIONS: Cleanse the skin thoroughly before applying medication one to three times daily. Because 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 one a day or every other day.

ACTIVE INGREDIENTS: Resorcinol 2%, Sulfur 8%.

INACTIVE INGREDIENTS: alcohol 15% (w/w), bentonite, carbopol, fragrance, iron oxides, octoxynol-0, potassium hydroxide, propylene glycol, titanium dioxide, water.

Store at controlled room temperature (59°-86°F)

D14048       Rev 5/16

Distributed by: Numark Brands, Inc. Edison, NJ 08818      1-800-331-0221

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