Label: HYDRA BOND MAXIMUM SKIN THERAPY CREAM- 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 October 12, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Dimethicone 2.0%

  • PURPOSE

    Purpose:

    Skin Protectant

  • INDICATIONS & USAGE

    Uses:

    Helps protect, prevent, and relieve dry, itchy, chaffed or chapped skin from the drying effects of the elements.

  • WARNINGS

    Warnings:

    For external use only

    When using this product, avoid contacting with eyes

  • STOP USE

    In case of accidental ingestion get medical help or contact a Poison Control Center immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions:

    Apply frequently and generously to skin as needed. Reapply to specific. extremely rough, dry, problem area to promote healing.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Glycerin, Petrolatum, Jojoba Ester, Cetyl Alcohol, Aloe Barbadensis Leaf Juice, Stearyl Alcohol, Distearyldimonium Chloride, Cetearyl Alcohol, Steareth-21, Steareth-2, Propylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Methyl Glueth-20, Tocopheryl Acetate (Vitamin E), Ascorbic Acid (Vitamin C), Panthenol (Vitamin B5), Retinol (Vitamin A), Hydrolyzed Collagen, Disodium EDTA, Fragrance, triethanolamine, Methylparaben, Propylparaben

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HYDRA BOND MAXIMUM SKIN THERAPY CREAM 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70990-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARETH-2 (UNII: V56DFE46J5)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    RETINOL (UNII: G2SH0XKK91)  
    DISODIUM HEDTA (UNII: KME849MC7A)  
    TRIETHANOLAMINE LAURATE (UNII: 9403LC9W1J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70990-004-01238 mL in 1 TUBE; Type 0: Not a Combination Product10/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/19/2016
    Labeler - Donegal Bay Ltd (068443618)
    Registrant - Donegal Bay Ltd (068443618)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANGZHOU KARIC COMMODITIES CO., LTD526884335manufacture(70990-004)
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