CALMOSEPTINE - zinc oxide and menthol ointment
Calmoseptine Inc.

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.

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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

Tube

tube

CALMOSEPTINE
zinc oxide and menthol ointment

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:0799-0001
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (ZINC OXIDE)	ZINC OXIDE	20.6 g in 113 g
MENTHOL (LEVOMENTHOL)	MENTHOL	0.44 g in 113 g

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE RED
Chlorothymol
Glycerin
Lanolin
Phenol
Sodium Bicarbonate
Thymol

#	Item Code	Package Description
Packaging
1	NDC:0799-0001-02	71 g in 1 TUBE
2	NDC:0799-0001-04	113 g in 1 TUBE
3	NDC:0799-0001-05	3.5 g in 1 PACKET

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/01/1950

Labeler - Calmoseptine Inc. (783409394)

Name	Address	ID/FEI	Business Operations
Establishment
Calmo Manufacturing Inc		015850149	manufacture, pack, label

Revised: 6/2012

Document Id: cd7952d3-f738-4f7b-a2d5-a23046bf5730

Set id: ff9539ed-d9ae-401d-adbc-df8f1d751431

Version: 7

Effective Time: 20120622

Calmoseptine Inc.