ACNEFREE BODY CLEARING- salicylic acid spray

AcneFree Body Clearing by

Drug Labeling and Warnings

AcneFree Body Clearing by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid 2.0%

Purpose

Acne treatment

Use

For the treatment of acne.

Warnings

For external use only

Do not use – If you have a known allergy to Salicylic Acid or aspirin.

Using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Stop use and ask a doctor if excessive irritation occurs.

When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth. If you have aspirin sensitivity, consult a physician prior to use.

Sunburn Alert - This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterward.

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

Directions

• Cleanse skin thoroughly before using medication
• Apply to entire affected area
• To avoid excessive dryness, start with one application daily, increasing to twice a day if needed
• If dryness is bothersome, reduce frequency of use

Inactive ingredients

Water, Alcohol Denat., Hamamelis Virginiana (Witch Hazel) Extract, Sorbitol, Glycerin, Glycolic Acid, Polysorbate 20, Sodium Hydroxide, Benzalkonium Chloride, Bisabolol, Zingiber Officinale (Ginger) Root Extract, Cocamidopropyl Dimethylamine, Polysorbate 80, Phenoxyethanol, Ethylhexylglycerin, Carthamus Tinctorius (Safflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Chamomila Recutita (Matricaria) Flower Extract, Leptogorgia Virgulata (Sea Whip) Extract, Butylene Glycol, Aloe Barbadensis Leaf Juice, Panthenol. Methylisothiazolinone, Niacinamide, Disodium EDTA, Lactic Acid

Other Information>

Store at 60° - 95° F (15° - 35° C).

Questions?

Toll-free number (800) 321-4576 www.AcneFree.com

PRINCIPAL DISPLAY PANEL - 142 g Bottle Label

NEW

AcneFree®
CLEAR SKIN TREATMENTS

Body Clearing
Acne Spray

2% Salicylic Acid
Glycolic Acid + Vitamin B3 + Aloe

CONTINUOUS SPRAY
for those hard-to-reach places

CLEARS BODY BREAKOUTS
FAST DRYING, NON-STICKY

NET WT. 5.0 OZ. (142 g)

INGREDIENTS AND APPEARANCE

ACNEFREE BODY CLEARING 
salicylic acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-5010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2.84 g  in 142 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOLIC ACID (UNII: 0WT12SX38S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
LEVOMENOL (UNII: 24WE03BX2T)
GINGER (UNII: C5529G5JPQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SAFFLOWER OIL (UNII: 65UEH262IS)
OLIVE OIL (UNII: 6UYK2W1W1E)
CHAMOMILE (UNII: FGL3685T2X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
NIACINAMIDE (UNII: 25X51I8RD4)
LACTIC ACID (UNII: 33X04XA5AT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-5010-05	142 g in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	01/14/2014

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	MANUFACTURE(0187-5010)