Label: RENEW DIMETHICONE SKIN PROTECTANT- skin protectant 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 January 17, 2020

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  • Active Ingredient:

    Dimethicone 5%

  • Purpose:

    Skin Protectant

  • Uses:

    • Forms a moisture barrier that prevents and helps treat effects associated with diaper rash from wetness, urine, or stool.
    • Temporarily protects and helps relieve chapped or cracked skin.
  • Warnings:

    • For external use only.
    • Avoid contact with eyes. In case of contact, flush thoroughly with water.
    • Stop use and ask a doctor if condition worsens or does not improve within 7 days.
    • Do not use on deep or punctured wounds.
  • Warnings:

    Keep out of reach of children. In case of accidental ingestion contact physician or Poison Control Center right away.

  • Directions:

    Clean skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply as necessary. If applying to perineal area, apply after each incontinent episode or diaper change to promote comfort and long lasting protection.

  • Other Information:

    Store at room temperature (59 o- 86 oF)

  • Inactive Ingredients:

    Aloe Barbadensis Leaf Juice, Aluminum Stearate, Cera Alba, Cholecalciferol, Chloroxylenol, Corn Oil, Imidiazolidinyl Urea, Dicocoyl Pentaerythrityl Distearyl Citrate, Fragrance, Lanolin, Methylparaben, Mineral Oil, Paraffin wax, Petrolatum, Phenoxyethanol, Propylene Glycol, Propylparaben, Retinyl Palmitate, Sorbitan Sesquioleate, Tocopheryl Acetate, Water.

  • Questions?

    Call 1-800-37-6296

  • Renew Skin Protectant Package Label Principal Display Panel

    Renew Dimethicone Skin Protectant tube labelRenew Dimethicone Skin Protectant 4ox box label

  • INGREDIENTS AND APPEARANCE
    RENEW DIMETHICONE SKIN PROTECTANT 
    skin protectant cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.05 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    CORN OIL (UNII: 8470G57WFM)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-410-055 g in 1 PACKET; Type 0: Not a Combination Product03/15/2012
    2NDC:61924-410-04113 g in 1 TUBE; Type 0: Not a Combination Product03/15/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/15/2012
    Labeler - Dermarite Industries LLC (883925562)
    Registrant - Dermarite Industries LLC (883925562)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermarite Industries LLC883925562manufacture(61924-410)
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