Label: FOTE SPACOLOGY SKIN PROTECTANT- white petrolatum jelly

  • NDC Code(s): 62217-046-59
  • Packager: FRUIT OF THE EARTH, INC.
  • 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 October 31, 2022

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  • Active ingredient

    White Petrolatum (100%)

  • Purpose

    Skin protectant (ointment)

  • 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

  • Stop use and ask a doctor if

    • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days

  • Do not use on

    • deep or puncture wounds • animal bites • seriuos burns

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply as needed.

  • Other information

    • may stain some fabrics
  • Label

    FOTE SPACOLOGY PETROLEUM JELLY 100% PURE

    7.5 OZ (212g)

    NDC 62217-046-59

    LabelFrontLabelBack1LabelBack2LabelBack3

  • INGREDIENTS AND APPEARANCE
    FOTE SPACOLOGY SKIN PROTECTANT 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-046
    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:62217-046-59212 g in 1 JAR; Type 0: Not a Combination Product02/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34602/27/2018
    Labeler - FRUIT OF THE EARTH, INC. (079559467)
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