Label: AMAR PETROLEUM- 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 April 21, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Petrolatum USP 99.8%

  • Purpose

    Skin Protectant

  • 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

    For external use only.

    When using this product

    • do not get into eyes.

    See a doctor if condition lasts more than 7 days.

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns.

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    apply as needed.

  • Inactive Ingredient

    Fragrance.

  • PRINCIPAL DISPLAY PANEL - 227 g Jar Label

    Amar®

    Petroleum Jelly

    All Purpose

    Adults

    Net Wt 8 oz (227 g)

    PRINCIPAL DISPLAY PANEL - 227 g Jar Label
  • INGREDIENTS AND APPEARANCE
    AMAR PETROLEUM   ALL PURPOSE ADULTS
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41499-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum99.8 g  in 100 g
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41499-105-01368 g in 1 JAR
    2NDC:41499-105-02283 g in 1 JAR
    3NDC:41499-105-03227 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34705/01/2010
    Labeler - Amar Remedies Limited (677141751)
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