Label: SA OIL FREE CREAM- salicylic acid cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72900-882-70 - Packager: Essay Cosmetics Group LLC
- 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 April 17, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- PURPOSE
- Use
- WARNINGS
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INSTRUCTIONS FOR USE
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 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 ■ if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
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INACTIVE INGREDIENT
Inactive ingredients Water, Glycerin, Dimethicone, Cetyl Alcohol, Propanediol, Isopropyl Myristate, Glyceryl Stearate, PEG-100 Stearate, Behentrimonium Methosulfate, Bisabolol, Cyclomethicone, Allantoin, Butylene Glycol, Tocopheryl Acetate, Propylene Glycol, Disodium EDTA, Diazolidinyl Urea, Iodopropynyl Butylcarbamate
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
● clean the skin thoroughly before applying this product
● cover the entire affected area with a thin layer one to three times daily
● 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
● if bothersome dryness or peeling occurs, reduce application to once a day or every other day. - Principal Display Panel
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INGREDIENTS AND APPEARANCE
SA OIL FREE CREAM
salicylic acid cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72900-882 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.5 g in 0.5 g Inactive Ingredients Ingredient Name Strength DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DIMETHICONE 350 (UNII: 2Y53S6ATLU) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) PEG-100 STEARATE (UNII: YD01N1999R) BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61) CYCLOMETHICONE (UNII: NMQ347994Z) ALLANTOIN (UNII: 344S277G0Z) .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) 1,2-PROPANEDIOL, 1-BENZOATE (UNII: K4K90ZQ89N) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) PROPANEDIOL (UNII: 5965N8W85T) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72900-882-70 0.5 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/28/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/28/2019 Labeler - Essay Cosmetics Group LLC (085448126)
