GLYCERIN, KAOLIN, CALAMINE, MENTHOL

FDA Drug Profile — Pranicura 5, No More Products

Drug Details

Generic Name
GLYCERIN, KAOLIN, CALAMINE, MENTHOL
Brand Names
Pranicura 5, No More Products
Application Number
M015
Sponsor
Sarati International, Inc.
NDC Codes
3
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
GLYCERIN, KAOLIN, MENTHOL, ZINC OXIDE

Indications and Usage

Uses • Helps relieve the itching and discomfort associated with anorectal disorders • Provides temporary relief from the symptoms of perianal skin irritation • For the temporary relief of itching associated with moist anorectal conditions • For the temporary relief of irritation and burning

Warnings

Warnings For rectal use only Do not use unless a prior doctor’s diagnosis of anorectal condition has been made When using this product do not exceed the recommended daily dosage unless directed by a doctor Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days • allergic reaction develops • symptoms being treated do not subside or if redness, irritation, swelling, pain, other symptoms develop or increase • Do not put this product into the rectum by using fingers or any mechanical device or applicator. • Remove petrolatum or greasy ointment before using this product because they interfere with the ability of this product to adhere properly to the skin area If pregnant or breastfeeding , ask a health professional before use