Label: PERSONAL CARE PETROLEUM- petrolatum 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 June 29, 2012

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

View All Sections
  • ACTIVE INGREDIENT



    Active ingredients White Petroleum 99.9%

  • PURPOSE



    Purpose  skin protectant

  • KEEP OUT OF REACH OF CHILDREN



    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Use helps prevent diaper rash



  • WARNINGS



    Warnings

    For external use only

    When using this product do not get into eyes

    See a doctor if condition worsens or lass more than 7 days

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


  • DOSAGE & ADMINISTRATION



    Directions

    change and cleanse diaper area and allow to dry

    apply product as needed, with each diaper change, especially at bedtime and when exposure to wet diapers may be prolonged

  • INACTIVE INGREDIENT



    Inactive ingredients  fragrance

  • PRINCIPAL DISPLAY PANEL

    label

    Personal Care

    100% Pure Petroleum Jelly

    Baby Fresh scent

    Net wt. 6 oz (170g)

    Distributed by:
    Personal Care Products, LLC

    Troy, Michigan 48084

    Made in India

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE PETROLEUM 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-8030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM170 g  in 170 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-8030-2170 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/01/2012
    Labeler - Personal Care Products (966155082)
    Registrant - Personal Care Products (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals726025211manufacture(29500-8030)
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!