ADULT ACNOMEL- resorcinol, sulfur cream

Adult Acnomel by

Drug Labeling and Warnings

Adult Acnomel by is a Otc medication manufactured, distributed, or labeled by NUMARK BRANDS, INC, Dhaliwal Pharmaceuticals Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

• Active Ingredients: Purpose
• 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

Questions? Call 1-800-331-0221

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

INGREDIENTS AND APPEARANCE

ADULT ACNOMEL  
resorcinol, sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69846-911
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Resorcinol (UNII: YUL4LO94HK) (Resorcinol - UNII:YUL4LO94HK)	Resorcinol	20 mg  in 1 g
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	80 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
Bentonite (UNII: A3N5ZCN45C)
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)
Ferric Oxide Red (UNII: 1K09F3G675)
Octoxynol-9 (UNII: 7JPC6Y25QS)
Potassium Hydroxide (UNII: WZH3C48M4T)
Propylene Glycol (UNII: 6DC9Q167V3)
Titanium Dioxide (UNII: 15FIX9V2JP)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69846-911-61	1 in 1 CARTON	10/08/1946
1		36 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/08/1946

Labeler - NUMARK BRANDS, INC (080184668)

Establishment
Name	Address	ID/FEI	Business Operations
Dhaliwal Pharmaceuticals Laboratories, LLC		116933772	manufacture(69846-911)