Label: SKIN PHARMACY ADVANCED ACNE THERAPY CLARIFYING DAILY CLEANSER- salicylic acid liquid
- NDC Code(s): 68634-064-01
- Packager: AMCOL Health & Beauty Solutions, Inc. DBA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 September 13, 2016
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SPL UNCLASSIFIED SECTION
HBS Code (Labeler): FP40604-5.1
Distributor: CVS Pharmacy, Inc.
Human OTC Drug
Active Ingredients: Salicylic Acid 2%
LABEL TEXT
________________________________________________________
SKIN+PHARMACY
ADVANCED ACNE THERAPY
CLARIFYING DAILY CLEANSER with Polytrap® Technology
Maximum Strength 2% Salicylic Acid
- removes excess skin oils
- unclogs pores
- oil-free formula
DERMATOLOGIST TESTED
exclusively at CVS/pharmacy
5 FL OZ (148 mL)
Skin+Pharmacy Advanced Acne Therapy is an innovative line of clinically tested skin care products that help reduce the appearance of acne. These products, exclusive to CVS/pharmacy, are less irritating to skin, yet powerful enough to treat breakouts, kill acne-causing bacteria, and unclog pores. Let Skin+Pharmacy help improve your appearance toward a clear, acne-free complexion.
The oil-free Clarifying Daily Cleanser is formulated with Polytrap®, a proven sebum oil absorber that can absorb up to 4 times its weight in skin oil. Maximum strength salicylic acid unclogs pores and deep cleans, leaving skin feeling refreshed. Use this product with the full Skin+Pharmacy Advanced Acne Therapy regimen.
Drug Facts
- Active Ingredient
- Purpose
- Warnings
- Do not use this medication if you
- Ask a doctor or pharmacist before use if you are
- When using this product
- Directions
-
Inactive ingredients
Water, Sodium C14-16 Olefin Sulfonate, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, DMDM Hydantoin, Disodium EDTA, Tocopheryl Acetate, Hamamelis Virginiana (Witch Hazel) Water, Butylene Glycol, Sodium Benzotriazolyl Butylphenol Sulfonate, Calendula Officinalis Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Phenoxyethanol, Yellow 5, Red 40, Fragrance.
Polytrap® is a registered trademark of AMCOL International Corp.
Save carton for complete labeling since all warnings are not included on the inner package.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2014 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in the U.S.A. of U.S. and imported components
V-31490
M050731
CVS® Quality
Money Back Guarantee
#971009
FP406
________________________________________________________
end of text
160913
AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care
301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com
lauren.haase@mineralstech.com
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SKIN PHARMACY ADVANCED ACNE THERAPY CLARIFYING DAILY CLEANSER
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68634-064 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ) salicylic acid 20 g in 2 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) sodium C14-16 olefin sulfonate (UNII: O9W3D3YF5U) polyethylene glycol 4000 (UNII: 4R4HFI6D95) cocamidopropyl betaine (UNII: 5OCF3O11KX) Xanthan gum (UNII: TTV12P4NEE) DMDM Hydantoin (UNII: BYR0546TOW) edetate disodium (UNII: 7FLD91C86K) .alpha.-tocopherol acetate, DL- (UNII: WR1WPI7EW8) Hamamelis virginiana flower water (UNII: 222MYC9QUV) Butylene glycol (UNII: 3XUS85K0RA) Calendula Officinalis flower (UNII: P0M7O4Y7YD) licorice (UNII: 61ZBX54883) Phenoxyethanol (UNII: HIE492ZZ3T) FD&C Yellow No. 5 (UNII: I753WB2F1M) FD&C red no. 40 (UNII: WZB9127XOA) Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer (UNII: EX0F4CZ66H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68634-064-01 148 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/01/2014 Labeler - AMCOL Health & Beauty Solutions, Inc. DBA (872684803) Establishment Name Address ID/FEI Business Operations AMCOL Health & Beauty Solutions, Inc. DBA 872684803 MANUFACTURE(68634-064) , PACK(68634-064) , LABEL(68634-064) , ANALYSIS(68634-064)
