Label: BEAUTY FOX ATOCLINIC- allantoin lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 30, 2015

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  • ACTIVE INGREDIENT

    ALLANTOIN 0.10%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    Helps to prevent dehydration of skin

  • DOSAGE & ADMINISTRATION

    Apply liberally as needed onto skin

  • WARNINGS

    For external use only.
    Do not use on damaged or broken skin.
    When using this product, keep out of eyes. Rinse with water to remove.
    Stop using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    Centella Asiatica Leaf Water, Purified Water, Water, Butylene Glycol, Centella Asiatica Extract, Glycerin, Cocos Nucifera (Coconut) Oil , Butylene Glycol Dicaprylate/Dicaprate, Cetyl Alcohol, Squalane, Stearyl Alcohol, Macadamia Seed Oil, Beeswax, Trehalose, Olea Europaea (Olive) Fruit Oil, Sorbitan Stearate , Cetearyl Olivate, Glyceryl Citrate/Lactate/Linoleate/Oleate, Shea Butter, Panthenol, Caprylyl Glycol, Sorbitan Olivate , Ammonium Acryloyldimethyltaurate/VP Copolymer, Coco-Caprylate/Caprate , Betaine, Allantoin, Caprylhydroxamic Acid, Glycosyl Trehalose, Hydrogenated Starch Hydrolysate, Dipotassium Glycyrrhizate, Portulaca Oleracea Extract, Adansonia Digitata Seed Oil, Beta-Glucan, Hippophae Rhamnoides Fruit Extract, Punica Granatum Seed Oil, Avocado Oil, Helianthus Annuus (Sunflower) Seed Oil, Hippophae Rhamnoides Fruit Extract, Hamamelis Virginiana (Witch Hazel) Water, Asiaticoside, Avena Sativa (Oat) Kernel Extract, Buddleja Davidii Extract, Thymus Vulgaris (Thyme) Extract, Madecassoside, Ceramide NP, 1,2-Hexanediol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Styrax Benzoin Resin Extract, Cedrus Atlantica Bark Oil, Anthemis Nobilis Flower Oil, Pelargonium Graveolens Flower Oil, Citrus Aurantium Dulcis (Orange) Flower Oil, Citrus Aurantium Dulcis (Orange) Oil, Rose Flower Oil, Michelia Alba Flower Oil, Rosemary Leaf Oil, Citrus Paradisi (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil , Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Eucalyptus Globulus Leaf Oil, Triticum Vulgare (Wheat) Sprout Extract, Brassica Oleracea Italica (Broccoli) Sprout Extract, Brassica Napus Sprout Extract, Phaseolus Radiatus Sprout Extract, Medicago Sativa (Alfalfa) Sprout Extract, Glycine Max (Soybean) Sprout Extract, Carthamus Tinctorius (Safflower) Sprout Extract, Lepidium Sativum Sprout Extract, Eugenia Caryophyllus (Clove) Bud Extract, Trifolium Repens Sprout Extract, Angelica Gigas Sprout Extract, Polygonum Fagopyrum (Buckwheat) Sprout Extract

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BEAUTY FOX ATOCLINIC 
    allantoin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70129-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.25 g  in 250 g
    Inactive Ingredients
    Ingredient NameStrength
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SQUALANE (UNII: GW89575KF9)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TREHALOSE (UNII: B8WCK70T7I)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    BETAINE (UNII: 3SCV180C9W)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    PURSLANE (UNII: M6S840WXG5)  
    ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
    CURDLAN (UNII: 6930DL209R)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    ASIATICOSIDE (UNII: PKO39VY215)  
    OAT (UNII: Z6J799EAJK)  
    THYME (UNII: CW657OBU4N)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    CERAMIDE NP (UNII: 4370DF050B)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)  
    CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW)  
    MAGNOLIA X ALBA FLOWER OIL (UNII: 8QDN200R1S)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    LEMON OIL (UNII: I9GRO824LL)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    WHEAT SPROUT (UNII: 3K32950CI0)  
    BROCCOLI SPROUT (UNII: 128UH9LOAE)  
    BEAN SPROUT (UNII: 9VZY890UEQ)  
    ALFALFA TOP (UNII: SQI2NBY9KR)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    GARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
    CLOVE (UNII: K48IKT5321)  
    ANGELICA GIGAS ROOT (UNII: 32766B2FHX)  
    BUCKWHEAT (UNII: N0Y68724R3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70129-002-021 in 1 CARTON09/30/2015
    1NDC:70129-002-01250 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/30/2015
    Labeler - Beauty Fox Co., Ltd. (688993629)
    Registrant - Beauty Fox Co., Ltd. (688993629)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beauty Fox Co., Ltd.688993629manufacture(70129-002)