SURE RESULT SR RENEW (DIMETHICONE) CREAM [INTERNATIONAL BRAND MANAGEMENT, LLC]

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SURE RESULT SR RENEW (DIMETHICONE) CREAM [INTERNATIONAL BRAND MANAGEMENT, LLC]
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NDC 69837-410-10
Set ID ed6374a9-4cbd-4037-88d0-ac01d1f00a29
Category HUMAN OTC DRUG LABEL
Packager International Brand Management, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT

    Active ingredient

    Dimethicone 5.0%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    -temporarily protects and help relieve chapped or cracked skin

  • WARNINGS

    Warnings

    For external use only

    Do not use on  -deep or puncture wounds   -animal bites

    -serious burns

    When using this product  -do not get into eyes

    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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical

    help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    -apply cream liberally as needed.

  • STORAGE AND HANDLING

    Other information

    -protect from freezing   avoid excessive heat

  • INACTIVE INGREDIENT

    Inactive Ingredients  Aloe Barbadensis Leaf (Aloe Vera Gel)

    Juice, Aqua (Deionized Water), Cetyl Alcohol, DEA-Cetyl

    Phosphate, Ethylhexylglycerin, Glyceryl Stearate, Glyceryl

    Stearate SE, C13-14 Isoparaffin, Laureth-7, Octyl Palmitate,

    PEG-100 Stearate, Phenoxyethanol, Polyacrylamide,

    Polysorbate-20, Propylene Glycol, Stearic Acid, Tocopheryl

    Acetate (Vitamin E).

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SURE RESULT SR RENEW 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69837-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69837-410-101 in 1 CARTON06/23/2017
    1118 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2016
    Labeler - International Brand Management, LLC (079794940)
    Establishment
    NameAddressID/FEIBusiness Operations
    International Brand Management, LLC079794940manufacture(69837-410)
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