Label: CALMOSEPTINE- zinc oxide and menthol ointment

  • 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 June 1, 2012

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  • 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
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