Label: CLASSIC CARE 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 May 8, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Petrolatum USP 100%

  • 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.

    Do not use on

    • deep or puncture wounds
    • laceration or infections
    • animal bites
    • serious burns

    Stop use and ask doctor if condition lasts more than 7 days.

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

  • Directions

    apply as needed

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    FDN Enterprises, LLC.
    Opa Locka, FL 33054.

  • PRINCIPAL DISPLAY PANEL - 510 g Jar Label

    Unscented

    Classic Care®

    PETROLEUM JELLY

    Skin Protectant

    Net Wt 18 Oz (510g)

    PRINCIPAL DISPLAY PANEL - 510 g Jar Label
  • INGREDIENTS AND APPEARANCE
    CLASSIC CARE   PETROLEUM
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60691-126
    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:60691-126-34510 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34705/30/2011
    Labeler - FDN Enterprises, LLC (965743867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vikshara Trading & Investments Ltd675920690MANUFACTURE(60691-126)
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