Label: PERSONAL CARE PETROLEUM JELLY SKIN PROTECTANT- white petroleum gel

  • 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 25, 2010

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients                                                                Purpose

    White Petroleum 100 percent...........................................Skin Protectant


  • PURPOSE

    Use: Provides relief to dry skin and lips when used regularly

    Offers soothing protection for minor burns

    Provides protection for skin from windburn and chapping

  • USER SAFETY WARNINGS

    Warnings:  For external use only

    Do not apply over deep puncture wounds, infections or lacerations

    If redness or swelling develops, consult a physician promptly

    Keep out of reach of children

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

    Avoid contact with eyes

  • DESCRIPTION

    Personal Care Products, Inc.

    Bingham Farms, MI 48025-2463

    Made in India

  • INDICATIONS & USAGE

    Personal Care
    Petroleum Jelly
    Skin Protectant
    Net Wt. 4oz (113 g)
  • PRINCIPAL DISPLAY PANEL

    PetroleumJelly4oz

  • DOSAGE & ADMINISTRATION

    Directions: Apply as needed

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE PETROLEUM JELLY SKIN PROTECTANT 
    white petroleum gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-8060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-8060-4113 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/25/2010
    Labeler - Personal Care Products, Inc (603124298)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!