Label: SKIN SAKE- petrolatum 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

    White Petrolatum

  • Purpose

    Soothes, Treats, Prevents,

    Skin Irritations
    Chafed Areas
    Incontinent Rashes
    Pressure Sores


  • Keep out of reach of children

    Keep out of reach of children.

  • Uses

    • Helps soothe, treat , and prevent skin breakdown
    • Repels wetness
    • Protects delicate skin
    • Relieves chapped, moist or irritated 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 puncture wounds, animal bites, serious burns.

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

  • Directions



    Cleanse and dry area.Apply a thin layer to skin as often as necessary.
    Store between 15° - 30° C, (59° - 86° F)

  • Inactive ingredients

    Peruvian Balsam, Aloe, Acidum Boricum, Vitamin E (Tocopherol), Zinc Oxide,  Mineral Oil, Castor Oil, White Beeswax.

  • Product Label

    NDC # 43447-2071-1
    SKIN®Sake ointment

    Soothes, Treats, Prevents
    Skin Irritations
    Chafed Areas
    Incontinence Rashes
    Pressure Sores

    Skin Protectant
    Moisture Barrier
    Aloe and Vit. E Added
    with Natural Peruvian Balsam

    Net Wt 2.5 oz (71g)

    Manufactured by:
    SKIN SAKE, LLC
    P.O. Box 390, Hamburg, AT 71646

    1-888-853-5544  skinsake.com

    SS SkinSake Label

  • INGREDIENTS AND APPEARANCE
    SKIN SAKE 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43447-2071
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM23 g  in 71 g
    Inactive Ingredients
    Ingredient NameStrength
    BALSAM PERU (UNII: 8P5F881OCY)  
    ALOE (UNII: V5VD430YW9)  
    BORIC ACID (UNII: R57ZHV85D4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43447-2071-171 g in 1 TUBE
    2NDC:43447-2071-0100 in 1 BOX
    2NDC:43447-2071-22 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34612/01/2005
    Labeler - Skin Sake, LLC (195912717)
    Registrant - Skin Sake, LLC (195912717)
    Establishment
    NameAddressID/FEIBusiness Operations
    Memphis Contract Packaging, Inc.185390010manufacture(43447-2071)
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