Label: WHITE PETROLATUM 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 March 24, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    White petrolatum 100%

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses

    • temporarily protects minor cuts, scrapes, and burns, and helps relieve chafed, chapped or cracked skin and lips.
    • helps prevent and protect from the drying effects of wind and cold weather
  • 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 in a few days

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions apply as needed

  • STORAGE AND HANDLING

    Store at room temperature, avoid excessive heat.

  • INACTIVE INGREDIENT

    water

  • PRINCIPAL DISPLAY PANEL

    petrolatum

    skin protectant

    Skin Savior_Final Label

  • INGREDIENTS AND APPEARANCE
    WHITE PETROLATUM 
    white petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81417-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81417-122-015 g in 1 TUBE; Type 0: Not a Combination Product03/24/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/24/2022
    Labeler - Sled Distribution, LLC (079772888)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sled Distribution, LLC079772888manufacture(81417-122)
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