Label: CLASSIC CARE PETROLEUM- white 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 September 15, 2021

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  • Drug Facts

  • Active Ingredients

    White Petrolatum USP (99.9%)

  • 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

    Water 

  • SPL UNCLASSIFIED SECTION

    PETROLEUM JELLY/ VASELINE

    Unscented

    Distributed by:

    FDN Enterprises, LLC.

    Opa Locka, FL 33054.

    Made In India

  • Packaging

    FDN-130

  • INGREDIENTS AND APPEARANCE
    CLASSIC CARE PETROLEUM 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60691-130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60691-130-011 in 1 BOX09/15/2021
    1510 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/15/2021
    Labeler - FDN Enterprises, LLC (965743867)
    Establishment
    NameAddressID/FEIBusiness Operations
    ORCHID LIFESCIENCES675474890manufacture(60691-130)
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