Label: BABY SOFT SCENT PETROLEUM- white petroleum 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 March 7, 2019

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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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