CALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [PHYSICIANS TOTAL CARE, INC.]

CALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [PHYSICIANS TOTAL CARE, INC.]
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NDC 54868-5287-0
Set ID 9aa48789-dc1c-452e-8125-f0cd0c792d5b
Category HUMAN OTC DRUG LABEL
Packager Physicians Total Care, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
  • Active Ingredients

    Menthol 0.44%
    Zinc Oxide 20.625%

  • Purpose

    External analgesic / Anti-itch
    Skin protectant / Anorectal astringent

  • Uses

    Uses: A moisture barrier that prevents and helps heal skin irritation from:

    urine, diarrhea, perspiration, fistula damage, feeding tube site leakage,

    wound drainage (peri-wound skin), minor burns, cuts, scrapes, itching

  • Warnings

    Warnings: For external use only. Not for deep or puncture wounds.  Avoid contact with eyes. 

    In case of accidental ingestion contact a physician or poison control center immediately.  If condition
    worsens or does not improve within 7 days, consult a doctor. 

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Directions

    Directions: Cleanse skin gently with mild skin cleanser.  Pat dry or allow to air dry.  Apply

    a thin layer of Calmoseptine 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. 

  • Inactive Ingredients

    Inactive ingredients: Calamine, chlorothymol, glycerin, lanolin, phenol,

    sodium bicarbonate, and thymol in a suitable ointment base

  • PRINCIPAL DISPLAY PANEL

    Calmoseptine Ointment

    Menthol 0.44%

    Zinc Oxide 20.6%

    71 gram tube

    NDC 54868-5287-0


    image of tube



    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma        74146

  • INGREDIENTS AND APPEARANCE
    CALMOSEPTINE 
    zinc oxide and menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5287(NDC:0799-0001)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.6 g  in 113 g
    MENTHOL (UNII: L7T10EIP3A) (LEVOMENTHOL - UNII:BZ1R15MTK7) MENTHOL0.44 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Chlorothymol (UNII: LJ25TI0CVT)  
    Glycerin (UNII: PDC6A3C0OX)  
    Lanolin (UNII: 7EV65EAW6H)  
    Phenol (UNII: 339NCG44TV)  
    Sodium Bicarbonate (UNII: 8MDF5V39QO)  
    Thymol (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5287-071 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/19/2006
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel