Zinc Oxide and Cocoa Butter

FDA Drug Profile — Calmol 4

Drug Details

Generic Name
Zinc Oxide and Cocoa Butter
Brand Names
Calmol 4
Application Number
M015
Sponsor
Resical Inc.
NDC Codes
1
Dosage Forms
SUPPOSITORY
Routes
RECTAL
Active Ingredients
COCOA BUTTER, ZINC OXIDE

Indications and Usage

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

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.