Label: AN12- allantoin, glycerin gel

  • NDC Code(s): 69318-001-01, 69318-001-02
  • Packager: DoctorAN
  • 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 October 24, 2014

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

  • ACTIVE INGREDIENT

    Dimethicone 1%

    Allantoin 2%

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  • PURPOSE

    Skin Protectant

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  • INDICATIONS & USAGE

    Breast Essence to help skin elasticity and beauty

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  • WARNINGS

    For external use only.

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  • DO NOT USE

    Do not use on damaged or broken skin.

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  • ASK DOCTOR

    Stop use and ask a doctor if rash or irritation, red spots, and swelling occur.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • WHEN USING

    When using this product, keep out of eyes.

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  • INSTRUCTIONS FOR USE

    Apply breast essence every morning and evening.

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  • INACTIVE INGREDIENT

    Pure water, Butylene glycol, Anemarrhena asphodeloides bunge extract, Propylene glycol, Cetyl alcohol, Glyceryl stearate/PEG-100-Stearate, Betaine, Arbutin, Phytrogen, Sorbitan sesquioleate, Polysorbate 80, Sorbitan stearate, Macadamia ternifolia seed oil, Simmondsia chinensis seed oil, Dipotassium glycyrrhizate, Triethanolamine, 1,2-hexandediol, Adenosine, Carbomer, Tocopheryl acetate, Sodium hyaluronate, Cultured wild ginseng roots extracts, Rose extract, Soybean extract, Portulaca oleracea extract, Perfume

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  • DOSAGE & ADMINISTRATION

    Apply appropriate amount of essence every morning and evening.

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  • INGREDIENTS AND APPEARANCE
    AN12 
    allantoin, glycerin gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69318-001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.3 mg  in 150 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 3 mg  in 150 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    SPANISH SARDINE (UNII: V837G5YR4R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    Decyl Glucoside (UNII: Z17H97EA6Y)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    CARICA PAPAYA LEAF (UNII: 66J7636Z2I)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    NEPIDERMIN (UNII: TZK30RF92W)  
    RICE BRAN (UNII: R60QEP13IC)  
    ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
    MUNG BEAN (UNII: 1LIB31N73G)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    PURSLANE (UNII: M6S840WXG5)  
    RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
    BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    PEG-60 CASTOR OIL (UNII: VXP26NM2XX)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    MENTHOL (UNII: L7T10EIP3A)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69318-001-02 1 in 1 CARTON 10/24/2014
    1 NDC:69318-001-01 150 mL in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/24/2014
    Labeler - DoctorAN (689060281)
    Registrant - DoctorAN (689060281)
    Establishment
    Name Address ID/FEI Business Operations
    DoctorAN 689060281 manufacture(69318-001)
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