Label: CLASSIC CARE BABY- 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 December 3, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    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 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

  • Inactive Ingredients

    Fragrance

  • PRINCIPAL DISPLAY PANEL - 368 g Bottle Label

    Classic Care ®

    Soft and gentle as a mother's embrace.

    Baby Petroleum Jelly

    NET WT 13 OZ (368g)

    Principal Display Panel - 368 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    CLASSIC CARE   BABY
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60691-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum998 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60691-123-31368 g in 1 CONTAINER
    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 & Investment Ltd675920690MANUFACTURE(60691-123)
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