ACNEFREE DAILY SKIN THERAPY ACNE WASH- salicylic acid liquid

AcneFree by

Drug Labeling and Warnings

AcneFree by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Ei LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Salicylic acid 2%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

When using this product avoid contact with eyes. If product gets into eye rinse thoroughly with water. Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Stop use and ask a doctor if irritation becomes severe.

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Use every morning and evening. Apply a dime-size amount to damp skin and gently massage, avoiding the eye area. Rinse well. Because excessive drying of the skin my occur, start with one application daily, then gradually increase to 2 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application use.

Other information

Store at controlled room temperature: 15oC-25oC (59oF-77oF). Keep away from heat and direct sunlight.

Inactive ingredients

water, sodium laureth sulfate, ethoxydiglycol, cocamidopropyl betaine, sodium lauryl sulfate, cetyl hydroxyethylcellulose, fragrance, ext. D&C violet 2, menthol, menthyl lactate, disodium EDTA, butyl avocadate

Questions or comments?

1-800-321-4576

PRINCIPAL DISPLAY PANEL – 4.8 FL OZ (142 mL) Bottle Label

NEW

AcneFree®

CLEAR SKIN TREATMENTS

Daily Skin Therapy

Acne Wash

2% Salicylic Acid Acne Treatment

1 AM Refresh Helps Prevent New Acne from Forming

Pore Targeting +

Patented Avocado

Extract Technology

4.8 FL OZ (142 mL)

INGREDIENTS AND APPEARANCE

ACNEFREE  DAILY SKIN THERAPY ACNE WASH
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-1638
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
D&C VIOLET NO. 2 (UNII: 350KA7O6HK)
MENTHOL (UNII: L7T10EIP3A)
METHYL LACTATE, L- (UNII: 0379G9C44S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
AVOCADO OIL (UNII: 6VNO72PFC1)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-1638-48	142 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/04/2016

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Ei LLC		105803274	MANUFACTURE(0187-1638) , PACK(0187-1638) , ANALYSIS(0187-1638) , LABEL(0187-1638)