Drug Facts

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)

Available from:

L'Oreal USA Products Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Acne treatment For the treatment of acne.

Authorization status:

OTC monograph final

Summary of Product characteristics

ACNEFREE DERMATOLOGY INSPIRED CARE BODY ACNE CLEARING- SALICYLIC
ACID SPRAY
L'OREAL USA PRODUCTS INC
_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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DRUG FACTS
ACTIVE INGREDIENT
Salicylic Acid 2.0%
PURPOS E
Acne treatment
US E
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