FORTINIA OF- clotrimazole 1% solution

Fortinia OF by

Drug Labeling and Warnings

Fortinia OF by is a Otc medication manufactured, distributed, or labeled by The Podiatree Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

cures most athlete’s foot infections and ringworm infections

relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

For external use only

Flammable

Do not use near heat or ame, or while smoking. Cap tightly and store at room temperature away from heat.

Do not use

on children under 2 years of age unless directed by a doctor.



When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor or pharmacist if

irritation occurs

there is no improvement within 4 weeks

KEEP OUT OF REACH OF CHILDREN.

In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Directions

wash affected area and dry thoroughly

apply one drop to the affected area twice daily (morning and night) or as directed by your doctor

using a disposable cotton swab, spread a thin layer over the affected area

discard cotton swab

supervise children in the use of this product

for athlete’s foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily

for athlete’s foot and ringworm infections, use daily for 4 weeks

this product is not effective on scalp or nails

Other Information

Store at controlled room temperature.

Inactive Ingredients

Ethyl Alcohol (79%), Propylene Glycol

Questions or Suggestions?

1.855.763.8733 or visit us at www.thepodiatreecompany.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FORTINIA OF 
clotrimazole 1% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54633-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54633-017-01	29.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	07/05/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	07/05/2017

Labeler - The Podiatree Company (078656000)