Label: PETROLEUM - petrolatum jelly

  • NDC Code(s): 29500-8040-2
  • 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 lasts 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. 3.52 oz (100 g)

    Distributed by: Personal Care products, LLC

    Troy, Michigan 48084 Made in India

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  • INGREDIENTS AND APPEARANCE
    PETROLEUM  
    petrolatum jelly
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:29500-8040
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Petrolatum (PETROLATUM) Petrolatum 99.9 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:29500-8040-2 100 g in 1 CONTAINER
    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(29500-8040)
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