Label: QUALITY PETROLEUM JELLY- white petroleum jelly
QUALITY PETROLEUM JELLY BABY FRESH SCENT- white petroleum jelly
QUALITY PETROLEUM COCOA BUTTER SCENT- white petroleum jelly
QUALITY PETROLEUM ALOE VERA- 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 August 15, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Yellow petroleum (100%)

  • Purpose

    Skin protectant

  • 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:

    For External Use Only.

    Do not use on:

    • deep and puncture wounds
    • lacerations or infections
    • serious burns
    • animal bites

    Stop use and ask doctor

    • If conditions does not improve or lasts more than 7 days

    Keep out of reach of children.

    • If swallowed get medical help or contact poison control center right away.
    • If redness or swelling develops consult a physician promptly.
  • Directions:

    • Apply as often as necessary.
  • Inactive Ingredients:

    Fragrance.

  • PRINCIPAL DISPLAY PANEL

    Quality
    Petroleum Jelly
    Protects, Soothes & Moisturizes
    Net Wt. 8 Oz. (226 g)

    Container Label

  • PRINCIPAL DISPLAY PANEL

    Quality
    Petroleum Jelly
    Protects, Soothes & Moisturizes
    Baby Fresh Scent
    Net Wt. 8 Oz. (226 g)

    Container Label

  • PRINCIPAL DISPLAY PANEL

    Quality
    Petroleum Jelly
    Protects, Soothes & Moisturizes
    Cocoa Butter Scent
    Net Wt. 8 Oz. (226 g)

    Container Label

  • PRINCIPAL DISPLAY PANEL

    Quality
    Petroleum Jelly
    Protects, Soothes & Moisturizes
    Aloe Vera
    Net Wt. 8 Oz. (226 g)

    Container Label

  • INGREDIENTS AND APPEARANCE
    QUALITY PETROLEUM JELLY 
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76384-001
    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:76384-001-01226 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34708/15/2011
    QUALITY PETROLEUM JELLY BABY FRESH SCENT 
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76384-002
    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:76384-002-01226 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34708/15/2011
    QUALITY PETROLEUM COCOA BUTTER SCENT 
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76384-003
    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:76384-003-01226 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34711/01/2010
    QUALITY PETROLEUM ALOE VERA 
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76384-004
    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:76384-004-01226 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34708/15/2011
    Labeler - Worldwide Sales & Distribution Corp. (627014330)
    Establishment
    NameAddressID/FEIBusiness Operations
    Steller Mercantile Pvt. Ltd.650493005MANUFACTURE
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