Label: PETROLEUM- petrolatum jelly

  • Category: HUMAN OTC DRUG LABEL

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 28, 2012

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  • 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 lasts 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. 3.52 oz (100 g)

    Distributed by: Personal Care products, LLC

    Troy, Michigan 48084 Made in India

  • INGREDIENTS AND APPEARANCE
    PETROLEUM  
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-8040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Petrolatum (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) Petrolatum99.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-8040-2100 g in 1 CONTAINER
    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(29500-8040)
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