Label: CLEANSING WIPES- salicylic acid swab
- NDC Code(s): 71613-001-01
- Packager: Nextcell Medical
- 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 July 28, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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Warnings
- For external use only
- Do not use if you have a known allergy to salicylic acid or asprin
- Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following the use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
- Stop use and ask a doctor if skin irritation occurs.
- Avoid contact with eyes. If contact occursm rinse eyes thoroughly with water.
- Avoid any uncessary sun exposure and use a sunscreen.
- Keep out of reach of children
- Directions
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Inactive ingredients
Alcohol, Aloe Barbadensis Leaf Extract, Aloe Barbadensis Leaf Juice, Alpha-Glucan Oligosaccharide, Amylopectin, Bioflavonoids, Brassica Oleracea, Italica (Broccoli) Extract, Capryloyl Glycine, Caprylyl Glycol, Cinnamomum Zeylanicum Barck Extract, Cocoamidopropyl PG-Dimonium, Chloride Phosphate, Decyl Glucoside, Dextrin, Ethylhexylglycerin, Hamamelis Virginiana (Witch Hazel) Water, Hexylene Glycol, Niacinamide, Phenoxyethanol, Polydextrose, Propanediol, Sarcosine, Water
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLEANSING WIPES
salicylic acid swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71613-001 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) witch hazel (UNII: 101I4J0U34) PROPANEDIOL (UNII: 5965N8W85T) ALOE VERA LEAF (UNII: ZY81Z83H0X) BRASSICA OLERACEA VAR. ITALICA WHOLE (UNII: DW4954EP53) 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 PG-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) CINNAMON BARK OIL (UNII: XE54U569EC) Product Characteristics Color white Score Shape RECTANGLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71613-001-01 25 in 1 POUCH 07/28/2017 1 3 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 07/28/2017 Labeler - Nextcell Medical (060650171) Registrant - Nextcell Medical (060650171) Establishment Name Address ID/FEI Business Operations Diamond Wipes International, Inc. 161104729 manufacture(71613-001)
