Label: FISHER-PRICE PETROLEUM JELLY- 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 29, 2022

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  • Drug Facts

  • Active Ingredient

    White Petrolatum USP (99.9%)

  • Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    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

    Do not use on ■ deep or puncture wounds, infections or lacerations ■ animal bites ■ serious burns. Ask a doctor.

    When using this product avoid contact with eyes.

    Stop use and ask a doctor if condition worsens or does not improve within 7 days.

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

  • DOSAGE & ADMINISTRATION

    Directions apply as needed

  • INACTIVE INGREDIENT

    Inactive ingredient Fragrance

  • SPL UNCLASSIFIED SECTION

    Protects minor cuts, scrapes and burns

    Skin Protectant

    Smart Care®

    FISHER-PRICE and associated trademarks are owned by and used under license from Mattel. ©2020 Mattel. All Rights Reserved.

    QUESTIONS OR COMMENTS?

    1-877-274-8358 Toll Free in USA • 1-909-434-0911 International

    COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

    DISTRIBUTED BY ASHTEL STUDIOS INC. ONTARIO, CALIFORNIA 91761

    DESIGNED IN U.S.A. • MADE IN INDIA

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    FISHER-PRICE PETROLEUM JELLY 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-068
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70108-068-01100 g in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/09/2020
    Labeler - Ashtel Studios, Inc (148689180)
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