Label: MENTHOL AND ZINC OXIDE ointment

  • 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 August 17, 2022

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  • Active Ingredients


    Menthol 0.44% w/w

    Zinc Oxide 20.625% w/w

  • Purpose

    Menthol 0.44% w/w…………….……External Analgesic

    Zinc Oxide 20.625% w/w………………. Skin Protectant

  • uses

    A moisture barrier that prevents and helps heal skin irritations from;

    • urine
    • diarrhea
    • perspiration
    • fistula drainage
    • feeding tube site leakage
    • wound drainage (peri-wound skin)
    • minor burns
    • cuts
    • scrapes
    • itching
  • Warnings:

    ■For external use only ■Not for deep or puncture wounds ■Avoid contact with 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

  • Keep Out Of Reach Of Children

    Keep Out Of Reach Of Children

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

  • Dosage & Administration:

    • Clean skin with mild skin cleanser
    • Pat dry or allow to air dry
    • Apply a thin layer of Calasoothe to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection
  • Inactive Ingredients

    Calamine, Glycerine, Lanolin, Light Liquid Paraffin, Petrolatum, Thymol, Tocopheryl Acetate

  • Principal Display Panel

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    MENTHOL AND ZINC OXIDE 
    menthol and zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69771-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.44 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.625 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    THYMOL (UNII: 3J50XA376E)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69771-013-23113 g in 1 TUBE; Type 0: Not a Combination Product08/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/17/2022
    Labeler - GERI-GENTLE CORPORATION (080367686)
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