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
Purpose

External Analgesic Skin Protectant

Description

Menthol 0.44% Zinc Oxide 20.625%

Medication Information

Warnings

For external use only



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

Purpose



External Analgesic

Skin Protectant

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.

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.

Inactive Ingredients

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

Description

Menthol 0.44% Zinc Oxide 20.625%

Questions?

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

Label

Calasoothe 4 oz. tube

Active Ingredient

Menthol 0.44%

Zinc Oxide 20.625%

Do Not Use Section

• On deep or puncture wounds

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

Warnings

For external use only



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

Purpose



External Analgesic

Skin Protectant

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.

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.

Inactive Ingredients

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

Questions?

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

Label

Calasoothe 4 oz. tube

Active Ingredient

Menthol 0.44%

Zinc Oxide 20.625%

Do Not Use Section (Do not use section)

• On deep or puncture wounds

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

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