Label: PURE 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 3, 2012

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  • ACTIVE INGREDIENT

    Active ingredient

    White Petrolatum USP (100 %)

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    For the temporary protection of minor cuts, scrapes and burns.

    • Helps relieve cracked or chapped lips and skin.
    • Helps to protect from the 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.
  • WARNINGS

    Warnings

    For External Use Only.

    Keep out of reach of children.

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

    When using this product

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply as needed.

  • INACTIVE INGREDIENT

    Inactive ingredients

    None

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    100% PURE PETROLEUM JELLY
    For all your moisturizing needs
    Net Wt. 4 oz. (113g) 4 onzas

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

  • INGREDIENTS AND APPEARANCE
    PURE PETROLEUM 
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52920-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52920-121-01225 g in 1 JAR
    2NDC:52920-121-1645 g in 1 JAR
    3NDC:52920-121-17100 g in 1 JAR
    4NDC:52920-121-18113 g in 1 JAR
    5NDC:52920-121-19170 g in 1 JAR
    6NDC:52920-121-20198 g in 1 JAR
    7NDC:52920-121-21283 g in 1 JAR
    8NDC:52920-121-22368 g in 1 JAR
    9NDC:52920-121-23450 g in 1 JAR
    10NDC:52920-121-24500 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34703/10/2010
    Labeler - Singhfam Corporation (019499958)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52920-121)
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