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Calmoseptine by Calmoseptine Inc.

Dosage form: ointment
Ingredients: ZINC OXIDE 20.6g in 113g, MENTHOL 0.44g in 113g
Labeler: Calmoseptine Inc.
NDC Code: 0799-0001

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 Facts

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

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

Tubetube
CALMOSEPTINE 
zinc oxide and menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0799-0001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE20.6 g  in 113 g
MENTHOL (LEVOMENTHOL) MENTHOL0.44 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED 
Chlorothymol 
Glycerin 
Lanolin 
Phenol 
Sodium Bicarbonate 
Thymol 
Packaging
#Item CodePackage Description
1NDC:0799-0001-0271 g in 1 TUBE
2NDC:0799-0001-04113 g in 1 TUBE
3NDC:0799-0001-053.5 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/1950
Labeler - Calmoseptine Inc. (783409394)
Establishment
NameAddressID/FEIOperations
Calmo Manufacturing Inc015850149manufacture, pack, label

Revised: 06/2012
 
Calmoseptine Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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