ACNEFREE BODY CLEARING- salicylic acid spray 
Bausch Health US LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Body Clearing Acne Spray

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)

Principal Display Panel - 142 g Bottle Label
ACNEFREE BODY CLEARING 
salicylic acid spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-5010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2.84 g  in 142 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-5010-05142 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/14/201408/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/14/201408/01/2017
Labeler - Bausch Health US LLC (831922468)

Revised: 1/2014
 
Bausch Health US LLC