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Acne Toner (Bioelements, Inc.)

Available Formats

Dosage Form Package Information Links
CREAM 1 BOTTLE in 1 CARTON (49825-130-04) > 236 mL in 1 BOTTLE (49825-130-03) Label Information
CREAM 1 BOTTLE in 1 CARTON (49825-130-02) > 88 mL in 1 BOTTLE (49825-130-01) Label Information

Complete Acne Toner Information

  • ACTIVE INGREDIENT

    Active ingredient             Purpose

    Salicylic Acid 0.5%         Acne treatment

    Uses

    For the treatment of acne

    Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away.

    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.

    warnings

    For external use only

    Directions

    Use after cleansing, day and night, avoiding eye area. Apply to cotton pad and gently wipe over skin. Do not rinse. If dryness or peeling occurs, reduce usage to once a day.

    Inactive ingredients

    Water (Aqua, Eau), Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, SD Alcohol, Pentylene Glycol, Hexylene Glycol, PEG-40 Hydrogenated Castor Oil, Glycerin, Vitis Vinifera (Grape) Fruit Extract, Mel (Honey) Extract (Miel Extrait de mile), Sodium Hydroxide, Ananas Sativus (Pineapple) Fruit Extract, Citrus Medica Limonium (Lemon) Fruit Extract, Citrus Aurantifolia (Lime) Fruit Extract, Lavandula Angustifolia(Lavender) Extract, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Citrus Grandis (Grapefruit) Peel Oil, Canarium Luzonicum Gum Nonvolatiles, Citrus Aurantium Dulcis (Orange) Oil, Caprylic/Capric Triglyceride, Lavandula Hybrida (Lavandin) Oil, Tetrahexyldecyl Ascorbate, Ethylhexylglycerin, Phenoxyethanol.


  • PRINCIPAL DISPLAY PANEL

    label

    primary

    secondary

    Biolelements

    Acne Clearing System

    Acne Toner

    0.5% salicylic acid acne treatment

    Hydrates, clears and eliminates excess oil

    88 mL / 3 Fl Oz


  • INGREDIENTS AND APPEARANCE
    ACNE TONER  BIOLEMENTS
    salicylic acid cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-130
    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
    WATER (UNII: 059QF0KO0R)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WINE GRAPE (UNII: 3GOV20705G)  
    HONEY (UNII: Y9H1V576FH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    LEMON (UNII: 24RS0A988O)  
    LIME (CITRUS) (UNII: 8CZS546954)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    ORANGE (UNII: 5EVU04N5QU)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    PAPAYA (UNII: KU94FIY6JB)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    ELEMI (UNII: C13XI009KO)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49825-130-02 1 in 1 CARTON
    1 NDC:49825-130-01 88 mL in 1 BOTTLE
    2 NDC:49825-130-04 1 in 1 CARTON
    2 NDC:49825-130-03 236 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 06/17/2013
    Labeler - Bioelements, Inc. (174813923)
    Registrant - Bioelements, Inc. (174813923)
    Establishment
    Name Address ID/FEI Business Operations
    Cosmetic Enterprises Ltd 017701475 manufacture(49825-130)