Label: MENTHOL AND ZINC OXIDE ointment

  • NDC Code(s): 67777-234-01, 67777-234-02, 67777-234-03, 67777-234-04
  • Packager: Dynarex Corporation
  • 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 23, 2022

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  • Active Ingredient

    Menthol 0.44%

    Zinc Oxide 20.625%

  • Purpose


    External Analgesic

    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


    When using this product

    • Avoid contact with eyes

    Do not use section

    • On deep or puncture wounds

    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

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Cleanse 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.

  • Other Information

    • Store at room temperature 15º-30º C (59º-86º F)

    • Tamper evident. Do not use if packet is torn or cut. Do not use if seal is damaged.

  • Inactive Ingredients

    Calamine, Glycerine, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol, White Soft Paraffin

  • Questions?

    1-888-DYNAREX Monday - Friday, 9AM - 5PM EST

  • Label

    1275 IN MASTERCalasoothe 4 oz. tube

  • Label

    1271 BX MASTER1271 Calasoothe

  • Label

    1271 BX STIS0101271 Calasoothe

  • INGREDIENTS AND APPEARANCE
    MENTHOL AND ZINC OXIDE 
    menthol and zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-234
    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 OXIDE21 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOL (UNII: 339NCG44TV)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    THYMOL (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-234-012 in 1 CASE05/11/2010
    1NDC:67777-234-02144 in 1 BOX
    13.5 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:67777-234-0324 in 1 CASE05/11/2010
    2NDC:67777-234-04113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/11/2010
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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