Label: ACNE CLEANSER AWAKEN BY QUALITY CHOICE- salicylic acid 2.00% liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 63868-777-05 - Packager: Quality Choice
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated January 9, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Use
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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.
- Directions
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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
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INGREDIENTS AND APPEARANCE
ACNE CLEANSER AWAKEN BY QUALITY CHOICE
salicylic acid 2.00% liquidProduct 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)