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Calmoseptine (Physicians Total Care, Inc.)

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OINTMENT 71 g in 1 TUBE (54868-5287-0) Label Information

Complete Calmoseptine Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5287(NDC:0799-0001)
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20.6 g  in 113 g
    MENTHOL (UNII: L7T10EIP3A) (LEVOMENTHOL - UNII:BZ1R15MTK7) MENTHOL 0.44 g  in 113 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54868-5287-0 71 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 07/19/2006
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel