Label: SKIN PHARMACY ADVANCED ACNE THERAPY TARGETED TREATMENT WIPES- benzoyl peroxide swab
- NDC Code(s): 68634-068-01
- 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 October 11, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
Ask a doctor of pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product.
When using this product
- Avoid unnecessary sun exposure and use a sunscreen.
- Avoid contact with lips, eyes, or mouth.
- Skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling.
- Irritation may be reduced by using the product less frequently or in lower concentration.
- Avoid contact with hair and dyed fabrics, which may be bleached by this product.
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Directions
- Clean the skin thoroughly before applying this product.
- Start with one application daily then gradually increase to 2-3 times daily as needed.
- If going outside apply sunscreen after using this product.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- Avoid storing at extreme temperatures (below 40°F and above 100°F).
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Inactive ingredients
Water, Caprylic/Capric Triglyceride, Propanediol, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Dimethicone, Cyclopentasiloxane, Steareth-20, Cyclohexasiloxane, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Xanthan Gum, Cetearyl Alcohol, Bentonite, Citric Acid, Sodium Citrate, Disodium EDTA, Ethylhexylglycerin, Sodium Hydroxide, Allantoin, Chamomilla Recutita (Matricaria) Flower Oil, Panthenol
Microsponge® is a registered trademark of AMCOL International Corp.
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M050735
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2014 CVS/pharmacy
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Made in the U.S.A. of U.S. and imported components
V-31490
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#971012
FP415
M050735
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Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Targeted Treatment Wipes Label
SKIN+PHARMACY
ADVANCED
ACNE THERAPYTARGETED TREATMENT WIPES
with Microsponge® Technology2.5% Benzoyl Peroxide
- effectively kills acne-causing bacteria
- promotes healthier, clearer skin
- fragrance free
DERMATOLOGIST TESTED
exclusively at
CVS/pharmacy10 pre-moistened wipes ● 3.5 x 3 in (8.9 x 7.6 cm)
M050744
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Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Targeted Treatment Wipes Carton Label
SKIN+PHARMACY
ADVANCED
ACNE THERAPYTARGETED TREATMENT WIPES
with Microsponge® Technology2.5% Benzoyl Peroxide
- effectively kills acne-causing bacteria
- promotes healthier, clearer skin
- fragrance free
DERMATOLOGIST TESTED
exclusively at
CVS/pharmacy2 packs/10 wipes each ● Total 20 pre-moistened wipes
3.5 x 3 in (8.9 x 7.6 cm)
-
INGREDIENTS AND APPEARANCE
SKIN PHARMACY ADVANCED ACNE THERAPY TARGETED TREATMENT WIPES
benzoyl peroxide swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68634-068 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength benzoyl peroxide (UNII: W9WZN9A0GM) (benzoyl peroxide - UNII:W9WZN9A0GM) benzoyl peroxide 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) medium-chain triglycerides (UNII: C9H2L21V7U) propanediol (UNII: 5965N8W85T) methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q) dimethicone (UNII: 92RU3N3Y1O) cyclomethicone 5 (UNII: 0THT5PCI0R) steareth-20 (UNII: L0Q8IK9E08) cyclomethicone 6 (UNII: XHK3U310BA) glyceryl monostearate (UNII: 230OU9XXE4) PEG-100 Stearate (UNII: YD01N1999R) phenoxyethanol (UNII: HIE492ZZ3T) xanthan gum (UNII: TTV12P4NEE) cetostearyl alcohol (UNII: 2DMT128M1S) bentonite (UNII: A3N5ZCN45C) citric acid monohydrate (UNII: 2968PHW8QP) sodium citrate (UNII: 1Q73Q2JULR) sodium hydroxide (UNII: 55X04QC32I) edetate disodium (UNII: 7FLD91C86K) ethylhexylglycerin (UNII: 147D247K3P) allantoin (UNII: 344S277G0Z) chamomile flower oil (UNII: 60F80Z61A9) panthenol (UNII: WV9CM0O67Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68634-068-01 2 in 1 CARTON 05/01/2014 1 10 in 1 PACKET 1 1.4 mL in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 05/01/2014 Labeler - AMCOL Health & Beauty Solutions, Inc. DBA (872684803) Establishment Name Address ID/FEI Business Operations AMCOL Health & Beauty Solutions, Inc. DBA 872684803 MANUFACTURE(68634-068) , PACK(68634-068) , LABEL(68634-068) , ANALYSIS(68634-068)