Label: PERSONAL CARE COCOA BUTTER SCENT- white petrolatum ointment

  • 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 April 23, 2018

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  • Active ingredient

    White petrolatum USP (99.9%)

  • Purpose

    Skin protectant

  • Uses

    ■ 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

  • Warnings

    For external use only

    Avoid contact with eyes

  • Stop use and ask a doctor if

    ■ condition worsens or does not improve after 7 days

  • Keep out of reach of children

    ■ if swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    ■ apply liberally, as often as necessary

  • Inactive Ingredients

    fragrance

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE  COCOA BUTTER SCENT
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-506
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72133-506-03100 g in 1 JAR; Type 0: Not a Combination Product04/09/2018
    2NDC:72133-506-06170 g in 1 JAR; Type 0: Not a Combination Product04/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/09/2018
    Labeler - Delta Brands & Products LLC (080999173)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Private Limited726025211manufacture(72133-506)
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