Calmoseptine Ointment

Drug Facts

Composition & Product

Active Ingredients

Lanolin (15.7 g) Menthol (0.44 g) Petrolatum (24 g) Zinc Oxide (20.6 g)

Inactive Ingredients

Ferric Oxide Red Chlorothymol Glycerin Phenol Sodium Bicarbonate Thymol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 1950-08-01

Medication Information

Purpose

Active Ingredients Purpose

Lanolin 15.7%...........................Anorectal Protectant

Menthol 0.44%...........................Anorectal Analgesic

Petrolatum 24%........................Anorectal Protectant

Zinc Oxide 20.6%......Anorectal Protectant, Astringent

Description

Lanolin 15.7% Menthol 0.44% Petrolatum 24% Zinc Oxide 20.6%

Uses

Temporarily protects irritated areas.
For the temporary relief of:
local itching and discomfort in the perianal area
pain or burning
skin irritations

Warnings

For external use only

Directions

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.

Gently dry by patting or blotting with toilet tissue or a soft cloth or air dry before application of this product.

Apply externally to the affected area up to 6 times daily or after each bowel movement.

Children under 12 years of age: consult a doctor.

Active Ingredients

Lanolin 15.7%

Menthol 0.44%

Petrolatum 24%

Zinc Oxide 20.6%

Calmoseptine Ointment

Inactive Ingredients:

calamine, chlorothymol, glycerin, phenol,

sodium bicarbonate, and thymol in a suitable ointment base

When Using This Product

* Certain persons can develop allergic reactions to ingredients in this product.

* Do not put this product into the rectum by using fingers or any mechanical device or applicator.

* Do not exceed the recommended daily dosage unless directed by a doctor.

* Avoid contact with eyes.

Stop Use and Ask Doctor If

condition worsens or does not improve within 7 days
bleeding occurs
symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

Keep Out of Reach of Children.

In case of accidental ingestion contact a physician or Poison Control Center immediately.

Structured Label Content

Uses

Temporarily protects irritated areas.
For the temporary relief of:
local itching and discomfort in the perianal area
pain or burning
skin irritations

Purpose

Active Ingredients Purpose

Lanolin 15.7%...........................Anorectal Protectant

Menthol 0.44%...........................Anorectal Analgesic

Petrolatum 24%........................Anorectal Protectant

Zinc Oxide 20.6%......Anorectal Protectant, Astringent

Warnings

For external use only

Directions

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.

Gently dry by patting or blotting with toilet tissue or a soft cloth or air dry before application of this product.

Apply externally to the affected area up to 6 times daily or after each bowel movement.

Children under 12 years of age: consult a doctor.

Active Ingredients

Lanolin 15.7%

Menthol 0.44%

Petrolatum 24%

Zinc Oxide 20.6%

Calmoseptine Ointment

Inactive Ingredients:

calamine, chlorothymol, glycerin, phenol,

sodium bicarbonate, and thymol in a suitable ointment base

When Using This Product (When using this product)

* Certain persons can develop allergic reactions to ingredients in this product.

* Do not put this product into the rectum by using fingers or any mechanical device or applicator.

* Do not exceed the recommended daily dosage unless directed by a doctor.

* Avoid contact with eyes.

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

condition worsens or does not improve within 7 days
bleeding occurs
symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion contact a physician or Poison Control Center immediately.

Advanced Ingredient Data

[{"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLOROTHYMOL", "unii": "LJ25TI0CVT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOL", "unii": "339NCG44TV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BICARBONATE", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "THYMOL", "unii": "3J50XA376E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "ACTIB", "strengthNumerator": "15.7", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "0.44", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "24", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "20.6", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily protects irritated areas. For the temporary relief of: local itching and discomfort in the perianal area pain or burning skin irritations", "Purpose": "Active Ingredients Purpose Lanolin 15.7%...........................Anorectal Protectant Menthol 0.44%...........................Anorectal Analgesic Petrolatum 24%........................Anorectal Protectant Zinc Oxide 20.6%......Anorectal Protectant, Astringent ", "Warnings": "For external use only", "Directions": "Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth or air dry before application of this product. Apply externally to the affected area up to 6 times daily or after each bowel movement. Children under 12 years of age: consult a doctor.", "Active Ingredients ": "Lanolin 15.7% Menthol 0.44% Petrolatum 24% Zinc Oxide 20.6%", "Inactive Ingredients:": "calamine, chlorothymol, glycerin, phenol, sodium bicarbonate, and thymol in a suitable ointment base", "When using this product": "* Certain persons can develop allergic reactions to ingredients in this product. * Do not put this product into the rectum by using fingers or any mechanical device or applicator. * Do not exceed the recommended daily dosage unless directed by a doctor. * Avoid contact with eyes.", "Stop use and ask doctor if": "condition worsens or does not improve within 7 days bleeding occurs symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.", "Keep out of reach of children.": "In case of accidental ingestion contact a physician or Poison Control Center immediately."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information