OIL FREE DAILY FACE WASH AWAKEN BY QUALITY CHOICE- salicylic acid cream
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.

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Drug Facts

Active ingredient Purpose
Salicylic Acid 2%.........................................Acne Treatment

Use For the treatment of acne.

Warnings
For external use only.

When using this product • skin irritation and dryness are 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.

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 a lather. • Massage face gently. • Rinse thoroughly.

Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Cetearyl Alcohol
Cistus Monspeliensis Extract
Disodium EDTA
Fragrance
Glycerin
Helichrysum Italicum Extract
Lavandula Stoechas Extract
Sodium Cocamidopropyl Betaine
Sodium Cocoyl Isethionate
Sodium Hydroxide
Sodium Laureth Sulfate
Water

image description

OIL FREE DAILY FACE WASH AWAKEN BY QUALITY CHOICE
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-780
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Salicylic Acid	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
Sodium Cocoyl Isethionate (UNII: 518XTE8493)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Glycerin (UNII: PDC6A3C0OX)
Sodium Laureth Sulfate (UNII: BPV390UAP0)
Sodium Hydroxide (UNII: 55X04QC32I)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAVANDULA STOECHAS FLOWERING TOP (UNII: 70759G2U6A)
HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-780-05	201 mL in 1 TUBE; Type 0: Not a Combination Product	09/26/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	09/26/2016

Labeler - Quality Choice (011920774)

Registrant - Product Quest Mfg (927768135)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quest Mfg		927768135	manufacture(63868-780) , label(63868-780)

Drug Facts

WarningsFor external use only.

Warnings
For external use only.