Label: CLEAR SMART CLEAR PORE HYDRATOR- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-249-01 - Packager: Jafra Cosmetics International 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 May 12, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- Clean the skin thoroughly before applying
- Cover the entire affected area with a thin layer 1 to 3 times daily
- Avoid contact with eyes.
- Becuase excessive drying may of the skin may occur, start with 1 application 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
Alcohol, Allantoin, Ammonium Acryloyldimethyltaurate/VP Copolymer, Bisabolol, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Decylene Glycol, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Honey Extract, Hydrogenated Lecithin, Lactobacillus Ferment, Laureth-7, Lecithin, Maltodextrin, Niacinamide, Panthenol, Phenethyl Alcohol, Phenoxyethanol, Polyacrylamide, Polyacrylate-13/Polyisobutene/Polysorbate-20, Royal Jelly Powder, Royal Jelly, Sodium Hydroxide, Sodium PCA,Spiraea Ulmaria Extract, Succinic Acid, Tetrapeptide-45, Water/Aqua, Zymomonas Ferment Extract
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLEAR SMART CLEAR PORE HYDRATOR
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-249 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 100 mL Inactive Ingredients Ingredient Name Strength DECYLENE GLYCOL (UNII: S57M60MI88) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) MALTODEXTRIN (UNII: 7CVR7L4A2D) SODIUM HYDROXIDE (UNII: 55X04QC32I) PANTHENOL (UNII: WV9CM0O67Z) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) HONEY (UNII: Y9H1V576FH) LACTOBACILLUS REUTERI (UNII: 9913I24QEE) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) ROYAL JELLY (UNII: L497I37F0C) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) SHEA BUTTER (UNII: K49155WL9Y) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) SUCCINIC ACID (UNII: AB6MNQ6J6L) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) NIACINAMIDE (UNII: 25X51I8RD4) ALLANTOIN (UNII: 344S277G0Z) DIPROPYLENE GLYCOL (UNII: E107L85C40) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) EDETATE DISODIUM (UNII: 7FLD91C86K) LAURETH-7 (UNII: Z95S6G8201) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) LEVOMENOL (UNII: 24WE03BX2T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-249-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 05/11/2020 Labeler - Jafra Cosmetics International Inc (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-249)
