ACNEFREE DAILY SKIN THERAPY ACNE PADS- salicylic acid solution

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

Flammable keep away from extreme heat or open flame

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.
• Limit use to the face and neck.

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.
• wipe the entire affected area 1 to 3 times daily
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 times daily 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 away from heat and direct sunlight. Keep jar tightly closed.

Inactive ingredients

water, SD alcohol 40-B, ethoxydiglycol, benzyl alcohol, fragrance, glycerin, menthoxypropanediol, benzalkonium chloride, menthol, menthyl lactate, ext. D&C violet 2

Questions/comments

1-800-321-4576

PRINCIPAL DISPLAY PANEL – 90 Pads 2.8in2 (18.1cm2) Jar Label

NEW

AcneFree®

CLEAR SKIN TREATMENTS

Daily Skin Therapy

Acne Pads

2% Salicylic Acid Acne Treatment

2 AM Treat Unclogs Pores and Tones Skin

Dermatologist

Tested

with

Soothing

Menthol

90 Pads

2.8in2 (18.1cm2)

INGREDIENTS AND APPEARANCE

ACNEFREE  DAILY SKIN THERAPY ACNE PADS
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-1639
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCERIN (UNII: PDC6A3C0OX)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
MENTHOL (UNII: L7T10EIP3A)
METHYL LACTATE, L- (UNII: 0379G9C44S)
D&C VIOLET NO. 2 (UNII: 350KA7O6HK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-1639-90	90 in 1 JAR; 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	01/29/2016

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Ei LLC		105803274	MANUFACTURE(0187-1639, 0187-1639) , PACK(0187-1639) , ANALYSIS(0187-1639)