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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Salicylic Acid 0.5% w/w Acne Treatment

  • PURPOSE

    Uses

    For treatment of Acne

    Clear acne blemishes

  • KEEP OUT OF REACH OF CHILDREN

    When using this product:

    Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water to remove.

    If irritation occurs, only use one topical medication

  • INDICATIONS & USAGE

    Stop use and ask a doctor:

    if skin irritation becomes severe

  • WARNINGS

    Warnings

    For External use only.

    • 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.
  • 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.

  • 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

    Ultraceuticals

    Ultra Clear Foaming Cleanser

    with Mandelic & Salicylic Acid

    Acne Face Cleanser

    150mL / 5.07 fl. Oz.

    Clear foaming cleanser

  • INGREDIENTS AND APPEARANCE
    ULTRA CLEAR FOAMING CLEANSER 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10028-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10028-050-01150 mL in 1 BOTTLE; Type 0: Not a Combination Product12/11/2019
    2NDC:10028-050-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product12/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00612/11/2019
    Labeler - ULTRACEUTICALS PTY LIMITED (744068995)