Label: ULTRA CLEAR FOAMING CLEANSER ACNE- salicylic acid lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 73122-125-01 - 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 25, 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 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 Ingredient
Water/Eau, Polysorbate 20, Methylpropanediol, Decyl Glucoside, PEG-120 Methyl Glucose Dioleate, Lactic Acid, Hamamelis Virginiana Water, Cocamidopropyl Betain, 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 ACNE
salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73122-125 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 METHYLPROPANEDIOL (UNII: N8F53B3R4R) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) LACTIC ACID (UNII: 33X04XA5AT) HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM HYDROXIDE (UNII: 55X04QC32I) POLYSORBATE 20 (UNII: 7T1F30V5YH) MANDELIC ACID (UNII: NH496X0UJX) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) ALLANTOIN (UNII: 344S277G0Z) EUCALYPTUS OIL (UNII: 2R04ONI662) SODIUM BENZOATE (UNII: OJ245FE5EU) DEHYDROACETIC ACID (UNII: 2KAG279R6R) SANTALUM SPICATUM OIL (UNII: H9LVS6REV4) PHENYLPROPANOL (UNII: 0F897O3O4M) NIACINAMIDE (UNII: 25X51I8RD4) BENZOIC ACID (UNII: 8SKN0B0MIM) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) CLOVE OIL (UNII: 578389D6D0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73122-125-01 150 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(73122-125)
