Label: PERSONAL CARE PETROLEUM- petrolatum jelly

  • NDC Code(s): 29500-8030-2
  • Packager: Personal Care Products
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/12

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

  • ACTIVE INGREDIENT



    Active ingredients White Petroleum 99.9%

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  • PURPOSE



    Purpose  skin protectant

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  • 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.

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  • INDICATIONS & USAGE

    Use helps prevent diaper rash



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  • 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.


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  • 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

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  • INACTIVE INGREDIENT



    Inactive ingredients  fragrance

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  • 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

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  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE PETROLEUM 
    petrolatum jelly
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:29500-8030
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (PETROLATUM) PETROLATUM 170 g  in 170 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:29500-8030-2 170 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 07/01/2012
    Labeler - Personal Care Products (966155082)
    Registrant - Personal Care Products (966155082)
    Establishment
    Name Address ID/FEI Business Operations
    Jell Pharmaceuticals 726025211 manufacture(29500-8030)
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