Label: NEXT CELL MEDICAL ACNE CLEANSING WIPES- 2% salicylic acid suitable for oily or acne-prone skin swab
- NDC Code(s): 62032-606-25
- Packager: OMP, Inc.
- 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 January 11, 2018
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- Drug Facts
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
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Directions
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- wipe the entire affected area one to three times daily to clean and treat skin
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- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
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- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
- Other information
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Inactive Ingredients
water (aqua), hamamelis virginiana (witch hazel) water, propanediol, aloe barbadensis leaf extract, aloe barbadensis leaf juice, brassica oleracea italica (broccoli) extract, cinnamomum zeylanicum bark extract, bioflavonoids, alpha-glucan oligosaccharide, decyl glucoside, dextrin, polydextrose, amylopectin, niacinamide, cocamidopropyl PG-dimonium chloride phosphate, sarcosine, capryloyl glycine, alcohol, hexylene glycol, ethylhexylglycerin, caprylyl glycol, phenoxyethanol
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INGREDIENTS AND APPEARANCE
NEXT CELL MEDICAL ACNE CLEANSING WIPES
2% salicylic acid suitable for oily or acne-prone skin swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-606 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 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) PROPANEDIOL (UNII: 5965N8W85T) ALOE VERA LEAF (UNII: ZY81Z83H0X) BRASSICA OLERACEA VAR. ITALICA WHOLE (UNII: DW4954EP53) CINNAMON (UNII: 5S29HWU6QB) CITRUS BIOFLAVONOIDS (UNII: BD70459I50) .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) ICODEXTRIN (UNII: 2NX48Z0A9G) POLYDEXTROSE (UNII: VH2XOU12IE) AMYLOPECTIN (UNII: 4XO4QFV777) NIACINAMIDE (UNII: 25X51I8RD4) COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) SARCOSINE (UNII: Z711V88R5F) CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) ALCOHOL (UNII: 3K9958V90M) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-606-25 25 in 1 POUCH; Type 0: Not a Combination Product 02/05/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/05/2018 Labeler - OMP, Inc. (790553353) Registrant - Valeant Pharmaceuticals North America LLC (042230623) Establishment Name Address ID/FEI Business Operations DIAMOND WIPES INTERNATIONAL, INC. 161104729 MANUFACTURE(62032-606)