Active Ingredients (In Each Suppository)
Cocoa Butter 76%
Zinc Oxide 10%
Calmol 4 Suppository
FDA Label NDC 67492-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Resical Inc. for the product Calmol 4 (NDC 67492-104). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each suppository), purpose, uses, warnings, when using this product, stop use and ask doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Protectant
Astringent
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
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
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.
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
Calmol 4 Suppository 24 Count
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.
Calmol Suppository 24ct (Calmo4supp24)
* Please review the disclaimer below.
