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

Acne Cleanser by

Drug Labeling and Warnings

Acne Cleanser by is a Otc medication manufactured, distributed, or labeled by Quality Choice, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Use

for the treatment of acne

WarningsFor 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE CLEANSER  AWAKEN BY QUALITY CHOICE
salicylic acid 2.00% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-777
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 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
CHAMOMILE (UNII: FGL3685T2X)
Cocamidopropyl PG-Dimonium Chloride Phosphate (UNII: H2KVQ74JM4)
Propylene Glycol (UNII: 6DC9Q167V3)
ALOE (UNII: V5VD430YW9)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
C12-15 Alkyl Lactate (UNII: GC844VRD7E)
PEG-80 Sorbitan Laurate (UNII: 239B50Y732)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-777-05	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/13/2014

Labeler - Quality Choice (011920774)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(63868-777) , label(63868-777)