Label: ADIPOWIN- glycerin, dimethicone cream

  • 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 February 1, 2017

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

  • Drug Facts
  • Active Ingredients

    Glycerin 6%, Dimethicone 0.5%

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  • Purpose

    Skin protectant

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  • USE

    Temporarily protects and helps relieve chapped or cracked skin.
    Beneficial for face, hands, body and legs.

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  • Warnings

    For external use only
    When using this product
    ● do not get into eyes and rinse with water to remove

    Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days 

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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  • Directions

    ● Cleanse skin. Apply cream liberally until entire area is covered.
    Apply as needed. Protect from freezing. Avoid excessive heat.

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  • Inactive Ingredients

    Water, Caprylic / Capric Triglyceride, Squalane, Butylene Glycol, Hydrogenated Polydecene, Macadamia Ternifolia Seed Oil, 1,2- Hexanediol, Cetearyl Alcohol, Glyceryl Stearate SE, C14-22 Alcohols, Aloe Barbadensis Leaf Extract, Portulaca Oleracea Extract, Jojoba Esters, Persea Gratissima (Avocado) Oil, C12-20 Alkyl Glucoside, Cetearyl Olivate, Behenyl Alcohol, Stearic Acid, Tromethamine, Sorbitan Olivate, Hydrogenated Lecithin, Carbomer, Xanthan Gum, Cholesterol, Tocopheryl Acetate, Ceramide NP, Phytosphingosine, Palmitoyl Tripeptide 54- Amide, Palmitoyl Tripeptide 53- Amide

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  • SPL UNCLASSIFIED SECTION

    Distributed by                                                 

    SupadElixir Co., Ltd.

    # 410, Building 1, School of Medicine, 

    1 Kangwondaehak-gil, Chuncheon-si,

    Gangwon-do, Korea

    www.SE-Tripeptide.com

    MADE IN KOREA

    Daily care

    Advanced Barrier Repair Cream

    for damaged face & body skin

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  • Packaging
  • INGREDIENTS AND APPEARANCE
    ADIPOWIN 
    glycerin, dimethicone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71200-605
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 60 mg  in 1 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SQUALANE (UNII: GW89575KF9)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PURSLANE (UNII: M6S840WXG5)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    PALMITOYL TRIPEPTIDE-54 AMIDE (UNII: VK1JT61H7N)  
    PALMITOYL TRIPEPTIDE-53 AMIDE (UNII: 06VMR2935X)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71200-605-10 100 mL in 1 TUBE; Type 0: Not a Combination Product 01/02/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 01/02/2017
    Labeler - Supadelixir Co Ltd (688481952)
    Establishment
    Name Address ID/FEI Business Operations
    Supadelixir Co Ltd 688481952 manufacture(71200-605)
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