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 July 27, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    White 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 eye.

    See a doctor if conditionlasts 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

    Amar ®

    Petroleum Jelly

    Cocoa Butter
    Scented

    100% HEALS
    DRYNESS

    Net Wt 8 oz (227 g)

    Principal Display Panel - 227 g Jar
  • INGREDIENTS AND APPEARANCE
    AMAR PETROLEUM   COCOA BUTTER SCENTED
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41499-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum99.8 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41499-125-01368 g in 1 JAR
    2NDC:41499-125-02283 g in 1 JAR
    3NDC:41499-125-03227 g in 1 JAR
    4NDC:41499-125-04113 g in 1 JAR
    5NDC:41499-125-05113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34707/01/2011
    Labeler - Amar Remedies Limited (677141751)
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