ACNE CLEANSER AWAKEN BY QUALITY CHOICE- salicylic acid 2.00% liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Quality Choice

INN (International Name):

Salicylic Acid

Composition:

Salicylic Acid 2 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

for the treatment of acne Allergy alert : Do not use this product if you have a known allergy to salicylic acid When using this product • 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. • Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Authorization status:

OTC monograph final

Summary of Product characteristics

ACNE CLEANSER AWAKEN BY QUALITY CHOICE- SALICYLIC ACID 2.00% LIQUID
QUALITY CHOICE
_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._
----------
DRUG FACTS
ACTIVE INGREDIENT PURPOSE
Salicylic Acid
2%......................................................................Acne
Treatment
US E
for the treatment of acne
WARNINGS
FOR EXTERNAL USE ONLY.
ALLERGY ALERT: Do not use this product if you have a known allergy to
salicylic acid
WHEN USING THIS PRODUCT • 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. • Avoid
contact with
eyes. If contact occurs, flush thoroughly with water.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a
Poison Control Center right away
DIRECTIONS
Cleanse twice a day. • Wet face. • Apply to hands, add
water and work into lather. • Massage face gently, rinse thoroughly.
INACTIVE INGREDIENTS
Water, Sodium C14-16
Olefin Sulfonate, Cocamidopropyl Betaine, Chamomilla
Recutita (Matricaria) Flower Extract, Cocamidopropyl
PG-Dimonium Chloride Phosphate, Propylene Glycol, Aloe
Barbadensis Leaf Extract, Anthemis Nobilis Flower Extract,
C12-15 Alkyl Lactate, PEG-80 Sorbitan Laurate, Disodium
EDTA, Benzalkonium Chloride, Fragrance, Yellow 5, Red
ACNE CLEANSER AWAKEN BY QUALITY CHOICE
salicylic acid 2.00% liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 38 6 8 -777
ROUTE OF ADMINISTRATION
TOPICAL
Quality Choice
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SA LICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Salicylic Acid
2 g in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WA TER (UNII: 0 59 QF0 KO0 R)
SO DIUM C14 -16 O LEFIN SULFO NA TE (UNII: O9 W3D3YF5U)
CO CA MIDO PRO PYL BETA INE (UNII: 5O