Label: BABY 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 October 4, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient

    White Petrolatum USP (99.9 %)

  • PURPOSE

    Purpose

    Skin Protectant

  • INACTIVE INGREDIENT

    Inactive Ingredient

    Fragrance

  • INDICATIONS & USAGE

    Uses

    Helps treat and prevent diaper rash.

    Other Uses:

    Temporarily protects minor cuts, scrapes and burns

    • Helps relieve cracked or chapped lips and skin
    • Helps protect from drying effects of wind and cold weather
    • Helps reduce the appearance of fine dry lines
    • May be used daily all over your body face and hands as needed
  • DOSAGE & ADMINISTRATION

    Directions

    Apply as needed

  • WARNINGS

    Warnings

    For External Use Only.

    Keep out of reach of children

    If swallowed get medical help or contact a poison control center immediately

    Avoid contact with eyes

    Do not use on

    • serious burns
    • deep or puncture wounds
    • animal bites

    See a doctor

    if condition lasts for 7 days

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL
    Baby Petroleum Jelly
    For all your moisturizing needs
    Net Wt. 4 oz. (113 g)
    4 onzas
    PRINCIPAL DISPLAY PANEL - 8oz

  • INGREDIENTS AND APPEARANCE
    BABY PETROLEUM 
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52920-126
    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:52920-126-2545 g in 1 JAR
    2NDC:52920-126-26100 g in 1 JAR
    3NDC:52920-126-27113 g in 1 JAR
    4NDC:52920-126-28170 g in 1 JAR
    5NDC:52920-126-29198 g in 1 JAR
    6NDC:52920-126-30225 g in 1 JAR
    7NDC:52920-126-31283 g in 1 JAR
    8NDC:52920-126-32368 g in 1 JAR
    9NDC:52920-126-33450 g in 1 JAR
    10NDC:52920-126-34500 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34710/01/2010
    Labeler - Singhfam Corporation (019499958)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52920-126)
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