Calmol 4 Suppositoires

SPL v12

SPL

SPL Set ID 5516f800-d3fa-4b90-a3eb-c0bdf3183b9b

Route

RECTAL

Published

Effective Date 2018-12-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (270 mg) Cocoa Butter (2052 mg)

Inactive Ingredients

Glyceryl Monostearate Fat, Hard Methylparaben Propylparaben Bismuth Subgallate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2006-05-13

Description

Cocoa Butter 76% Zinc Oxide 10%

Purpose

Protectant Astringent

Medication Information

Purpose

Protectant

Astringent

Description

Cocoa Butter 76% Zinc Oxide 10%

Uses

gives temporary relief of burning, irritation, itching and discomfort associated with hemorrhoids
temporarily provides a coating for for anorectal discomforts
temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

For rectal use only

Directions

adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad
gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
detach one suppository from the strip; remove wrapper before inserting into rectum as follows:
- slowly peel down film wrapper by pulling evenly and slowly on tabs to expose suppository
insert 1 suppository bulb shape first into the rectum up to 6 times daily or after each bowl movement
children under 12 years of age, consult a doctor

Other Information

store in a cool place not ober 80°F to avoid melting
if subjected to higher temperatures, refrigeration may restore to a usable condition

Inactive Ingredients

Bismuth subgallate, glyceryl stearate, hydrogenated vegetable oil, methylparaben, propylparaben

Questions Or Comments?

Call toll-free 1-800-204-6434 weekdays 9 AM to 5 PM EST

When Using This Product

do not exceed the recommended daily dosage unless directed by a doctor

Stop Use and Ask Doctor If

bleeding occurs or if condition worsens or does not improve within 7 days

Calmol 4 Suppository 24 Count

CALMOL 24ct_R0625.p1.pdf

Calmol 4 Hemorrhoidal Suppository

24 count

Distributed by: Resical Inc.

Orchard Park, New York 14127

The image below depicts a representative sample of packaging that is available.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Suppository)

Cocoa Butter 76%

Zinc Oxide 10%

Structured Label Content

Uses

gives temporary relief of burning, irritation, itching and discomfort associated with hemorrhoids
temporarily provides a coating for for anorectal discomforts
temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Purpose

Protectant

Astringent

Warnings

For rectal use only

Directions

adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad
gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
detach one suppository from the strip; remove wrapper before inserting into rectum as follows:
- slowly peel down film wrapper by pulling evenly and slowly on tabs to expose suppository
insert 1 suppository bulb shape first into the rectum up to 6 times daily or after each bowl movement
children under 12 years of age, consult a doctor

Other Information (Other information)

store in a cool place not ober 80°F to avoid melting
if subjected to higher temperatures, refrigeration may restore to a usable condition

Inactive Ingredients (Inactive ingredients)

Bismuth subgallate, glyceryl stearate, hydrogenated vegetable oil, methylparaben, propylparaben

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-204-6434 weekdays 9 AM to 5 PM EST

When Using This Product (When using this product)

do not exceed the recommended daily dosage unless directed by a doctor

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

bleeding occurs or if condition worsens or does not improve within 7 days

Calmol 4 Suppository 24 Count (Calmol 4 Suppository 24 count)

CALMOL 24ct_R0625.p1.pdf

Calmol 4 Hemorrhoidal Suppository

24 count

Distributed by: Resical Inc.

Orchard Park, New York 14127

The image below depicts a representative sample of packaging that is available.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Suppository) (Active Ingredients (in each suppository))

Cocoa Butter 76%

Zinc Oxide 10%

Advanced Ingredient Data

[{"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FAT, HARD", "unii": "8334LX7S21", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "270", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "COCOA BUTTER", "unii": "512OYT1CRR", "classCode": "ACTIB", "strengthNumerator": "2052", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "BISMUTH SUBGALLATE", "unii": "YIW503MI7V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "gives temporary relief of burning, irritation, itching and discomfort associated with hemorrhoids temporarily provides a coating for for anorectal discomforts temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful", "Purpose": "Protectant Astringent", "Warnings": "For rectal use only", "Directions": "adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product detach one suppository from the strip; remove wrapper before inserting into rectum as follows: slowly peel down film wrapper by pulling evenly and slowly on tabs to expose suppository insert 1 suppository bulb shape first into the rectum up to 6 times daily or after each bowl movement children under 12 years of age, consult a doctor", "Other information": "store in a cool place not ober 80°F to avoid melting if subjected to higher temperatures, refrigeration may restore to a usable condition", "Inactive ingredients": "Bismuth subgallate, glyceryl stearate, hydrogenated vegetable oil, methylparaben, propylparaben", "Questions or comments?": "Call toll-free 1-800-204-6434 weekdays 9 AM to 5 PM EST", "When using this product": "do not exceed the recommended daily dosage unless directed by a doctor", "Stop use and ask doctor if": "bleeding occurs or if condition worsens or does not improve within 7 days", "Calmol 4 Suppository 24 count": "CALMOL 24ct_R0625.p1.pdf Calmol 4 Hemorrhoidal Suppository 24 count Distributed by: Resical Inc. Orchard Park, New York 14127 The image below depicts a representative sample of packaging that is available.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Active Ingredients (in each suppository)": "Cocoa Butter 76% Zinc Oxide 10%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:48.389704 · Updated: 2026-03-14T23:13:10.446567