ACNEFREE DERMATOLOGY INSPIRED CARE BODY ACNE CLEARING- salicylic acid spray

AcneFree Dermatology Inspired Care Body Acne Clearing by

Drug Labeling and Warnings

AcneFree Dermatology Inspired Care Body Acne Clearing by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ACNEFREE DERMATOLOGY INSPIRED CARE BODY ACNE CLEARING 
salicylic acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-010
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: 49967-010-01	142 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/04/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	12/04/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, Inc. (DBA: PakLab)		790530976	MANUFACTURE(49967-010)