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.

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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.


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

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ACNE CLEANSER  AWAKEN BY QUALITY CHOICE
salicylic acid 2.00% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-777
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-777-05177 mL in 1 BOTTLE; Type 0: Not a Combination Product11/13/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/13/2014
Labeler - Quality Choice (011920774)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(63868-777) , label(63868-777)

Revised: 1/2018
Document Id: ba131043-833e-4c9d-82b8-767efe8517e3
Set id: c91ddc7b-b1d1-4bfe-9923-aa6e75e3979d
Version: 1
Effective Time: 20180109
 
Quality Choice