Label: PETROLEUM JELLY BABY FRAGRANCE- petrolatum jelly

  • NDC Code(s): 22431-134-01
  • Packager: Blue Cross Laboratories, Inc.
  • 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 November 13, 2020

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

  • ACTIVE INGREDIENT

    Active ingredients Purpose

    White Petrolatum USP(100%) Skin Protectant

  • PURPOSE

    Uses

    • Baby Petroleum Jelly Restores smooth and healthy skin
    • Helps to soothe dry, chapped, cracked, or irritated skin and lips due to cold and wind
    • for the temporary protection of minor cuts, scrapes, burns and sunburn
    • helps to treat and prevent diaper rash
  • 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

    Stop use and ask a doctor if condition worsens or does not improve after 7 days

  • WARNINGS

    Warnings

    For external use only

    Avoid Contact with eyes

  • DOSAGE & ADMINISTRATION

    Directions

    apply liberally, as often as necessary

  • INACTIVE INGREDIENT

    Inactive Ingredients fragrance

  • PRINCIPAL DISPLAY PANEL

    Baby Days

    Petroleum Jelly Baby Fragrance

    Net Wt. 6 oz. 

    Baby Petro jelly

  • INGREDIENTS AND APPEARANCE
    PETROLEUM JELLY BABY FRAGRANCE 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-134
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9   in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22431-134-01170 g in 1 JAR; Type 0: Not a Combination Product01/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/25/2019
    Labeler - Blue Cross Laboratories, Inc. (008298879)
    Registrant - Blue Cross Laboratories, Inc. (008298879)
    Establishment
    NameAddressID/FEIBusiness Operations
    ROYAL EXPORTS650621381manufacture(22431-134)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Private Limited726025211manufacture(22431-134)