Label: BUDPAK PETROLEUM COCOA BUTTER- white petrolatum 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 February 14, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient

    White Petrolatum USP  99.9%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    Temporarily protects minor cuts, scrapes, 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

    See a doctor if condition lasts 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 Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply as needed.

  • SPL UNCLASSIFIED SECTION

    Other Information

    Store at 20°to 25°C (68° to 77°F).

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Theobroma Cacao (Cocoa) Seed Butter,  Fragrance.

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    Budpak Petroleum Cocoa Butter Jelly

    White Petrolatum 99.9%

    NET WT 0.5 OZ (14 g)

  • PRINCIPAL DISPLAY PANEL

    image of package label

  • INGREDIENTS AND APPEARANCE
    BUDPAK PETROLEUM COCOA BUTTER 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27293-029-141 in 1 BOX
    114 g in 1 TUBE
    2NDC:27293-029-281 in 1 BOX
    228 g in 1 TUBE
    3NDC:27293-029-351 in 1 BOX
    335 g in 1 TUBE
    4NDC:27293-029-421 in 1 BOX
    442 g in 1 TUBE
    5NDC:27293-029-021 in 1 BOX
    5113 g in 1 TUBE
    6NDC:27293-029-031 in 1 BOX
    6226 g in 1 TUBE
    7NDC:27293-029-04453 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/14/2014
    Labeler - Budpak Inc. (183224849)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-029)
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