Skip to Content

← See all Calmoseptine brands

Calmoseptine by Physicians Total Care, Inc.

Dosage form: ointment
Ingredients: ZINC OXIDE 20.6g in 113g, MENTHOL 0.44g in 113g
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-5287

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

PRINCIPAL DISPLAY PANEL

Calmoseptine Ointment

Menthol 0.44%

Zinc Oxide 20.6%

71 gram tube

NDC 54868-5287-0




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

CALMOSEPTINE 
zinc oxide and menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5287(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: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/FEIOperations
Physicians Total Care, Inc.194123980relabel

 
Physicians Total Care, Inc.

← See all Calmoseptine brands

Medically reviewed on Jun 1, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

More about Calmoseptine (lanolin / menthol / petrolatum / zinc oxide topical)

Related treatment guides

Hide