Label: ULTRA CLEAR FOAMING CLEANSER- salicylic acid lotion
- NDC Code(s): 10028-050-01, 10028-050-02
- 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
- 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 and rinse thoroughly 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, Polysorbate 20, Methylpropanediol, Decyl Glucoside, PEG-120 Methyl Glucose Dioleate, Lactic Acid, Hamamelis Virginiana Water, Cocamidopropyl Betaine, Sodium Hydroxide, Mandelic Acid, Caprylyl Glycol, Sodium Lauroyl Lactylate, Allantoin, Sodium Chloride, Sodium PCA, Disodium EDTA, Phenylpropanol, Niacinamide, Disodium Lauriminodipropionate Tocopheryl Phosphates, Eucalyptus Globulus Leaf Oil, Fusanus Spicatus Wood Oil, Eugenia Caryophyllus (Clove) Bud Oil, Sodium Benzoate, Benzoic acid, Phenoxyethanol, Dehydroacetic Acid.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ULTRA CLEAR FOAMING CLEANSER
salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10028-050 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 PHENYLPROPANOL (UNII: 0F897O3O4M) NIACINAMIDE (UNII: 25X51I8RD4) SANTALUM SPICATUM OIL (UNII: H9LVS6REV4) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) LACTIC ACID (UNII: 33X04XA5AT) HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) CLOVE OIL (UNII: 578389D6D0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) ALLANTOIN (UNII: 344S277G0Z) POLYSORBATE 20 (UNII: 7T1F30V5YH) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) SODIUM BENZOATE (UNII: OJ245FE5EU) MANDELIC ACID (UNII: NH496X0UJX) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) METHYLPROPANEDIOL (UNII: N8F53B3R4R) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) DEHYDROACETIC ACID (UNII: 2KAG279R6R) BENZOIC ACID (UNII: 8SKN0B0MIM) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM (UNII: 7FLD91C86K) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10028-050-01 150 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2019 2 NDC:10028-050-02 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 12/11/2019 Labeler - ULTRACEUTICALS PTY LIMITED (744068995)