Label: PETROLEUM JELLY BABY FRESH SCENT 3.53OZ- petrolatum ointment

  • NDC Code(s): 57337-162-01
  • Packager: Rejoice International Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 13, 2024

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  • Active ingredient

    Petrolatum 99.6%

  • Purpose

    Skin protectant

  • Use

    • helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
  • Warnings

    For external use only

    When using this product

    When using this product do not get into eyes.

    Stop use and ask a doctor if

    • condition worsens
    • symtoms last more than 7 days or clear up and occur again within a few days.

    Do not use

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children

    • if swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • apply as needed.
  • Inactive ingredient

    Fragrance

  • label

    label

  • INGREDIENTS AND APPEARANCE
    PETROLEUM JELLY BABY FRESH SCENT 3.53OZ 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-162
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-162-01100 g in 1 JAR; Type 0: Not a Combination Product03/06/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01603/06/2024
    Labeler - Rejoice International Corp. (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    Astonea Labs Private Limited878533295manufacture(57337-162)
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