Label: SURE RESULT SR RENEW- 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 June 23, 2017

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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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