Label: SALICYLIC ACID cream
- NDC Code(s): 0363-0017-26
- Packager: WALGREEN COMPANY
- 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 September 23, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Keep out of reach of children
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Directions
- clean the skin thoroughly before applying this product
- cover the entire affected area with a thin layer one to three times daily
- because excessive dryng of the skin may occur, start with one application daily, then gradualy increast to two or three times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce application to nce a day or every other day
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Inactive ingredients
arachidyl alcohol, arachidyl glucoside, behenyl alcohol, BHT, bis-phenylpropyl dimethicone, C12-15 alkyl benzoate, C13-14 isoparaffin, cetearyl alcohol, cetearyl glucoside, dimethicone, disodium EDTA, ethylene/acrylic acid copolymer, fragrance, glycerin, Glycine soja (soybean) seed extract, isoceteth-20, laureth-7, methyl gluceth-20, polyacrylamide, PPG-10 cetyl ether, sodium hydroxide, water
- SPL UNCLASSIFIED SECTION
- principal display panel
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INGREDIENTS AND APPEARANCE
SALICYLIC ACID
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 5.05 mg in 1 mL Inactive Ingredients Ingredient Name Strength ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) DOCOSANOL (UNII: 9G1OE216XY) BIS-PHENYLPROPYL DIMETHICONE (15 CST) (UNII: 4836494CFT) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) dimethicone (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I) GLYCERIN (UNII: PDC6A3C0OX) SOYBEAN (UNII: L7HT8F1ZOD) ISOCETETH-20 (UNII: O020065R7Z) laureth-7 (UNII: Z95S6G8201) METHYL GLUCETH-20 (UNII: J3QD0LD11P) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) PPG-10 CETYL ETHER (UNII: Q056X4917J) SODIUM HYDROXIDE (UNII: 55X04QC32I) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0017-26 1 in 1 CARTON 12/19/2015 1 118 mL in 1 BOTTLE, PUMP; 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 12/19/2015 Labeler - WALGREEN COMPANY (008965063) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(0363-0017) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(0363-0017)
