1271 Calasoothe Ointment Ndc 67777-234-01

1271 Calasoothe Ointment Ndc 67777-234-01
SPL v13
SPL
SPL Set ID d0e43651-4215-465b-9ace-1bc23126b109
Route
TOPICAL
Published
Effective Date 2022-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.44 g) Zinc Oxide (21 g)
Inactive Ingredients
Ferric Oxide Red White Petrolatum Glycerin Phenol Lanolin Mineral Oil Sodium Bicarbonate Thymol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-05-11
Description

Menthol 0.44% Zinc Oxide 20.625%

Purpose

External Analgesic Skin Protectant

Medication Information

Purpose



External Analgesic

Skin Protectant

Description

Menthol 0.44% Zinc Oxide 20.625%

Uses

• A moisture barrier that prevents and helps heal skin irritations from:

• Urine • Diarrhea • Perspiration • Fistula drainage • Feeding tube site leakage • Wound drainage (peri-wound skin) • Minor burns

• Cuts • Scrapes • Itching

Label

Calasoothe 4 oz. tube

Warnings

For external use only



Directions

• Cleanse skin with mild skin cleanser.

• Pat dry or allow to air dry.

• Apply a thin layer of Calasoothe to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Questions?

1-888-DYNAREX Monday - Friday, 9AM - 5PM EST

Active Ingredient

Menthol 0.44%

Zinc Oxide 20.625%

Other Information

• Store at room temperature 15º-30º C (59º-86º F)

• Tamper evident. Do not use if packet is torn or cut. Do not use if seal is damaged.

Do Not Use Section

• On deep or puncture wounds

Inactive Ingredients

Calamine, Glycerine, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol, White Soft Paraffin

When Using This Product

• Avoid contact with eyes

Stop Use and Ask A Doctor If

• Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Structured Label Content

Uses

• A moisture barrier that prevents and helps heal skin irritations from:

• Urine • Diarrhea • Perspiration • Fistula drainage • Feeding tube site leakage • Wound drainage (peri-wound skin) • Minor burns

• Cuts • Scrapes • Itching

Label

Calasoothe 4 oz. tube

Purpose



External Analgesic

Skin Protectant

Warnings

For external use only



Directions

• Cleanse skin with mild skin cleanser.

• Pat dry or allow to air dry.

• Apply a thin layer of Calasoothe to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Questions?

1-888-DYNAREX Monday - Friday, 9AM - 5PM EST

Active Ingredient

Menthol 0.44%

Zinc Oxide 20.625%

Other Information

• Store at room temperature 15º-30º C (59º-86º F)

• Tamper evident. Do not use if packet is torn or cut. Do not use if seal is damaged.

Do Not Use Section (Do not use section)

• On deep or puncture wounds

Inactive Ingredients

Calamine, Glycerine, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol, White Soft Paraffin

When Using This Product (When using this product)

• Avoid contact with eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:30.067961 · Updated: 2026-03-14T23:05:17.700396