Label: ULTRA CLEAR TREATMENT- salicylic acid lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 73122-126-01 - Packager: Ultraceuticals US 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 September 26, 2019
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- 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 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 dryness or peeling occurs, reduce application to once a day or every other day.
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INACTIVE INGREDIENT
Inactive ingredients:
Water/Eau, PPG-15 Stearyl Ether, Arginine, Glycerin, Mandelic Acid, Niacinamide, Tribehenin PEG-20 Esters, Ethoxydiglycol, Methylpropanediol, Cetearyl Alcohol, Disodium Laurimodipropionate Tocopheryl Phosphates, Dimethicone, Bentonite, Caprylyl Glycol, Allantoin, Bisabolol, Hydrated Silica, Sodium PCA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate Crosspolymer-6 Xanthan Gum, Disodium EDTA, Phenylpropanol, Eucalyptus Globulus Leaf Oil, Fusanus Spicata Wood Oil, Phenoxyethanol, Eugenia Caryophyllus (Clove) Bud Oil, Aloe Barbadensis Leaf Juice Powder, Maltodextrin, T-Butyl Alcohol, Benzoic Acid, Dehydroacetic Acid.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ULTRA CLEAR TREATMENT
salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73122-126 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 MANDELIC ACID (UNII: NH496X0UJX) METHYLPROPANEDIOL (UNII: N8F53B3R4R) ALLANTOIN (UNII: 344S277G0Z) MALTODEXTRIN (UNII: 7CVR7L4A2D) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) XANTHAN GUM (UNII: TTV12P4NEE) PHENYLPROPANOL (UNII: 0F897O3O4M) EUCALYPTUS OIL (UNII: 2R04ONI662) ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZOIC ACID (UNII: 8SKN0B0MIM) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) EDETATE DISODIUM (UNII: 7FLD91C86K) CLOVE OIL (UNII: 578389D6D0) SANTALUM SPICATUM OIL (UNII: H9LVS6REV4) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M) DIMETHICONE (UNII: 92RU3N3Y1O) BENTONITE (UNII: A3N5ZCN45C) CAPRYLYL GLYCOL (UNII: 00YIU5438U) LEVOMENOL (UNII: 24WE03BX2T) WATER (UNII: 059QF0KO0R) PPG-15 STEARYL ETHER (UNII: 1II18XLS1L) ARGININE (UNII: 94ZLA3W45F) GLYCERIN (UNII: PDC6A3C0OX) NIACINAMIDE (UNII: 25X51I8RD4) TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9) DEHYDROACETIC ACID (UNII: 2KAG279R6R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73122-126-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/26/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 09/26/2019 Labeler - Ultraceuticals US LLC (117022448) Establishment Name Address ID/FEI Business Operations Baxter Laboratories Pty. Ltd. 740537709 manufacture(73122-126)
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