Label: MENTHOL AND ZINC OXIDE ointment

  • NDC Code(s): 77338-013-23
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 25, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • 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:77338-013
    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
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    THYMOL (UNII: 3J50XA376E)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-013-23113 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 DrugM01608/17/2022
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!