Label: SKIN SAKE SURFACE PROTECTANT- dimethicone ointment

  • 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 April 24, 2013

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  • Active Ingredient

    Drug Facts

    Active Ingredient

    Dimethicone 2%

  • Purpose

    Skin Protectant

  • Keep out of reach of children

    Keep out of reach of children.

  • Uses

    • Helps soothe, treat, and prevent ulcer-prone areas, cracked skin, rashes
    • Repels wetness
    • Protects delicate skin
    • Relieves chapped, moist areas
    • Prevents friction
  • Warnings

    For external use only.

    When using this product, do not get into eyes.

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

    Do not use on deep or punctured wounds, animal bites, serious burns.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Cleanse and dry area. Apply liberally as often as necessary, at least 4 or 5 times per day. Re-apply as needed.

    Store between 15° -30° C, (59° -86° F)

  • Inactive ingredients

    Aloe Barbadensis Extract, Acidium Boricum, Castor Oil, Cholecalciferol (Vitamin D), Cod Liver Oil, Green 6, Microcrystalline Wax, Mineral Oil, Myroxylon pereirae (Balsam Peru) Resin, Red 17, Vitamin A, Vitamin E, White Petrolatum, White Wax, Yellow 11

  • Product Label

    www.skinsake.com


    SKIN SAKE

    Surface Protectant

    PHARMACIST FORMULATED

    Soothes and Prevents:

    Ulcer-Prone Areas
    Reddened/Cracked Skin
    Incontinent Rashes
    Chafed Areas

    Repels Wetness
    Vitamin A, D, E, and Aloe

    NET WT 4OZ  SP02

    Manufactured for:

    Skin Sake

    P.O. Box 390

    Hamburg, AR 71646

    1-888-853-5544

    681441-00

    SS Surface-Protectant Label

  • INGREDIENTS AND APPEARANCE
    SKIN SAKE SURFACE PROTECTANT 
    dimethicone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43447-4410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2.272 g  in 113.6 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    BALSAM PERU (UNII: 8P5F881OCY)  
    D&C RED NO. 17 (UNII: ND733RX3JN)  
    VITAMIN A (UNII: 81G40H8B0T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    D&C YELLOW NO. 11 (UNII: 44F3HYL954)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43447-4410-0113.6 g in 1 TUBE
    2NDC:43447-4410-2100 in 1 BOX
    2NDC:43447-4410-18 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/01/2009
    Labeler - Skin Sake, LLC (195912717)
    Registrant - Skin Sake, LLC (195912717)
    Establishment
    NameAddressID/FEIBusiness Operations
    Memphis Contract Packaging, Inc.185390010manufacture(43447-4410)
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