Label: PERSONAL CARE PRODUCTS 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

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  • ACTIVE INGREDIENT

    Active ingredients

    White petroleum jelly 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



    Uses temporarily protects and helps relieve chapped or cracked skin and lips

  • WARNINGS



    Warnings

    For external use only

    When using this product do not get into eyes

    See a doctor if condition lasts more than 7 days

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

  • DOSAGE & ADMINISTRATION



    Directions apply as needed

  • INACTIVE INGREDIENT



    Inactive ingredients  fragrance

  • PRINCIPAL DISPLAY PANEL

    label


    Personal Care
    100% Petroleum Jelly
    Cocoa Butter scent
    Net wt. 6 oz (170 g)
    Distributed by:
    Personal Care Products, LLC
    Troy, Michigan 48084
    Made in India

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE PRODUCTS PETROLEUM  
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-8050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-8050-3170 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34606/29/2012
    Labeler - Personal Care Products (966155082)
    Registrant - Personal Care Products (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals726025211manufacture(29500-8050)
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