Label: ULTRA CLEAR TREATMENT- salicylic acid lotion
- NDC Code(s): 10028-051-01, 10028-051-02
- Packager: ULTRACEUTICALS PTY LIMITED
- 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 1, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
Warnings
For external use only.
When using this product
Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water to remove. -
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.
- If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
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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:10028-051 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 LEVOMENOL (UNII: 24WE03BX2T) HYDRATED SILICA (UNII: Y6O7T4G8P9) XANTHAN GUM (UNII: TTV12P4NEE) DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M) BENTONITE (UNII: A3N5ZCN45C) SANTALUM SPICATUM OIL (UNII: H9LVS6REV4) WATER (UNII: 059QF0KO0R) CLOVE OIL (UNII: 578389D6D0) ALOE VERA LEAF (UNII: ZY81Z83H0X) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) BENZOIC ACID (UNII: 8SKN0B0MIM) DEHYDROACETIC ACID (UNII: 2KAG279R6R) PPG-15 STEARYL ETHER (UNII: 1II18XLS1L) ARGININE (UNII: 94ZLA3W45F) GLYCERIN (UNII: PDC6A3C0OX) NIACINAMIDE (UNII: 25X51I8RD4) TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9) ALLANTOIN (UNII: 344S277G0Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) MALTODEXTRIN (UNII: 7CVR7L4A2D) METHYLPROPANEDIOL (UNII: N8F53B3R4R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONE (UNII: 92RU3N3Y1O) CAPRYLYL GLYCOL (UNII: 00YIU5438U) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENYLPROPANOL (UNII: 0F897O3O4M) MANDELIC ACID (UNII: NH496X0UJX) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) EUCALYPTUS OIL (UNII: 2R04ONI662) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10028-051-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/15/2019 2 NDC:10028-051-02 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 12/15/2019 Labeler - ULTRACEUTICALS PTY LIMITED (744068995)
