BABY SOFT SCENT PETROLEUM (WHITE PETROLEUM) JELLY [BLUE CROSS LABORATORIES, INC.]

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BABY SOFT SCENT PETROLEUM (WHITE PETROLEUM) JELLY [BLUE CROSS LABORATORIES, INC.]
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NDC 22431-706-01, 22431-706-02, 22431-706-03, 22431-706-04, 22431-706-05
Set ID 82bd5d2b-a0e4-11d2-e053-2a91aa0a9f96
Category HUMAN OTC DRUG LABEL
Packager Blue Cross Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT

    Active ingredient

    White petrolatum USP (99.9 %)

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses

    • helps to soothe dry, chapped, cracked or irritated skin and lip due to cold and wind
    • for the temporary protection of minor cuts, scrapes, burns and sunburn
  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally, as often as necessary
  • INACTIVE INGREDIENT

    Inactive ingredients

    Fragrance

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    BABY SOFT SCENT PETROLEUM JELLY
    Skin Protectant
    NET WT. 6 OZ (170 g)

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL 100% PURE PETROLEUM JELLY Net Wt. 8 fl. oz. (250g) 8 onzas

  • INGREDIENTS AND APPEARANCE
    BABY SOFT SCENT PETROLEUM 
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-706
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM0.99 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22431-706-01113 g in 1 JAR; Type 0: Not a Combination Product02/25/2019
    2NDC:22431-706-02170 g in 1 JAR; Type 0: Not a Combination Product02/25/2019
    3NDC:22431-706-03226 g in 1 JAR; Type 0: Not a Combination Product02/25/2019
    4NDC:22431-706-04270 g in 1 JAR; Type 0: Not a Combination Product02/25/2019
    5NDC:22431-706-05368 g in 1 JAR; Type 0: Not a Combination Product02/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/25/2019
    Labeler - Blue Cross Laboratories, Inc. (008298879)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(22431-706)
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