ADULT ACNOMEL TINTED- resorcinol 2% sulfur 8% cream

Adult Acnomel Tinted by

Drug Labeling and Warnings

Adult Acnomel Tinted by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients..............................Purpose

Resorcinol 2% .....................................Acne Treatment ointment

Sulfur 8 % ........................................... Acne Treatment

DOSAGE

cover the entire affected area with a thin layer one to three times daily.

Uses

• for the treatment of acne
• clears up most acne pimples
• helps prevent new 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 it 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 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 throughly 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 occur, 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, carpobol, fragrance, iron oxides, octoxynol-9, potassium hydroxide, propylene glycol, titanium dioxide, water

PRINCIPAL DISPLAY PANEL

Label

INGREDIENTS AND APPEARANCE

ADULT ACNOMEL TINTED 
resorcinol 2% sulfur 8% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	2 g  in 100 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BENTONITE (UNII: A3N5ZCN45C)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
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: 0295-9116-01	7 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2017
2	NDC: 0295-9116-09	36 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/01/2017

Labeler - Denison Pharmaceuticals, Inc. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, Inc.		001207208	manufacture(0295-9116)