Label: BUDPAK PETROLEUM- 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 July 7, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient

    White Petrolatum USP (100%)

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    • Temporarily protects minor cuts, scrapes or burns.

    • Temporarily protects and helps relieve chapped or cracked skin and lips.

    • Helps protect from the drying effects of wind and cold weather.

  • WARNINGS

    Warnings

    For external use only.

  • WHEN USING

    When using this product do not get into eyes.

  • STOP USE

    Stop use and ask a doctor if

    • conditions last more than 7 days.

  • DO NOT USE

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions

    Apply as needed.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    None

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    BUDPAK PETROLEUM JELLY

    NET WT. 8 OZ. (226g)

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    BUDPAK PETROLEUM 
    petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27293-033-06113 g in 1 BOTTLE
    2NDC:27293-033-13170 g in 1 BOTTLE
    3NDC:27293-033-12226 g in 1 BOTTLE
    4NDC:27293-033-07283 g in 1 BOTTLE
    5NDC:27293-033-11368 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/07/2014
    Labeler - Budpak Inc. (183224849)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(27293-033)
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