Label: PETROLEUM JELLY FRESH SCENT- white petroleum jelly

  • 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 October 21, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient White Petroleum (99.9%)

  • INACTIVE INGREDIENT

    Ingredient Perfume (0.1%)

  • PURPOSE

    Purpose Skin Protectant

  • INDICATIONS & USAGE

    Uses : Temporarily protects & helps relieve minor cuts, scrapes, burns & chapped or cracked skin & lips.

    Helps protect from the drying effects of wind & cold weather.

  • WARNINGS

    WARNING: FOR EXTERNAL USE ONLY

  • DO NOT USE

    DO NOT USE ON: Deep Wounds/Puncture Wounds Lacerations/Infections . Serious Burns . Animal Bites

  • STOP USE

    STOP USE AND ASK DOCTOR If condition does not improve or lasts more than 7 days.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN If swallowed get medical help or contact Poison Control right away. If redness or swelling develops, consult a physician

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Apply to clean & dry area as necessary.

  • PACKAGE DISPLAY

    Package Display

  • INGREDIENTS AND APPEARANCE
    PETROLEUM JELLY  FRESH SCENT
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-003-01226 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/21/2010
    Labeler - International Wholesale Inc. (161872676)
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