Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (20.6 g) Levomenthol (0.44 g)

Inactive Ingredients

Ferric Oxide Red Chlorothymol Glycerin Lanolin Phenol Sodium Bicarbonate Thymol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2006-07-19

Medication Information

Purpose

External analgesic / Anti-itch

Skin protectant / Anorectal astringent

Description

Menthol 0.44% Zinc Oxide 20.625%

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

Section 50565-1

Keep out of reach of children

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.

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.

Active Ingredients

Menthol 0.44%

Zinc Oxide 20.625%

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

Structured Label Content

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

Section 50565-1 (50565-1)

Keep out of reach of children

Purpose

External analgesic / Anti-itch

Skin protectant / Anorectal astringent

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.

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.

Active Ingredients

Menthol 0.44%

Zinc Oxide 20.625%

Inactive Ingredients

Inactive ingredients: Calamine, chlorothymol, glycerin, lanolin, phenol,

sodium bicarbonate, and thymol in a suitable ointment base

Principal Display Panel (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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "50565-1": "Keep out of reach of children", "Purpose": "External analgesic / Anti-itch Skin protectant / Anorectal astringent", "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. ", "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. ", "Active Ingredients": "Menthol 0.44% Zinc Oxide 20.625%", "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"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information