Label: CALPROTECT- menthol, zinc oxide ointment

  • NDC Code(s): 69618-067-71, 69618-067-82
  • Packager: Reliable 1 Laboratories LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 12, 2023

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  • Drug Facts

  • Active ingredients

    Menthol 0.44%

    Zinc Oxide 20.6%

  • Purpose

    External analgesic / Anti-itch

    Skin protectant / Anorectal astrigent

  • Uses

    A moisture barrier that prevents and helps heal skin irritations from

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

    For external use only

    • Not for deep or puncture wounds
    • Avoid contact with eyes
    • Incase of accidental ingestion, contact a physician or posion contril immediately
    • If condition worsens or does not improve in 7 days, consult a doctor
    • Do not put this product into the rectum by using fingers or any machanical device or applicator
    • Children under 12 years of age: consult a doctor
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Directions

    Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Calprotect Ointment 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 between 15-30°C (59-86°F)

  • Inactive ingredients

    calamine, chlorothymol, glycerin, lanolin, phenol, sodium bicarbonate, and thymol in a suitable ointment base

  • Questions or comments?

    1-516-341-0666 8:30 am-4:30 pm EST Mon-Fri

  • PRINCIPAL DISPLAY PANEL

    Protects, Soothes & Promotes Healing

    NDC 69618-067-82

    Compare to active ingredients in Calmoseptine*

    CalProtect Ointment

    External use only

    Made in the USA

    *Reliable-1 Labs is not affiliated with the owner of the registered trademark Calmoseptine

    Calprotect 113g Tube

  • INGREDIENTS AND APPEARANCE
    CALPROTECT 
    menthol, zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-067
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.6 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.44 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOL (UNII: 339NCG44TV)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    THYMOL (UNII: 3J50XA376E)  
    LANOLIN (UNII: 7EV65EAW6H)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CHLOROTHYMOL (UNII: LJ25TI0CVT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-067-82113 g in 1 TUBE; Type 0: Not a Combination Product01/01/2021
    2NDC:69618-067-7171 g in 1 JAR; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01501/01/2021
    Labeler - Reliable 1 Laboratories LLC (079718111)
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