FORTINIA- clotrimazole 1% solution

Fortinia by

Drug Labeling and Warnings

Fortinia 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

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

Aloe barbadensis leaf extract, lavandula augustifolia (lavender) oil, olea europaea (olive) leaf extract, PEG 400, polysorbate 80, SD alcohol (9.75%), tocopheryl acetate (Vitamin E), tritium vulgare (wheat) germ oil

Questions or Suggestions?

1.855.763.8733 or visit us at www.thepodiatreecompany.com

PRINCIPAL DISPLAY PANEL

Label

INGREDIENTS AND APPEARANCE

FORTINIA 
clotrimazole 1% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54633-214
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
ALOE (UNII: V5VD430YW9)
LAVENDER OIL (UNII: ZBP1YXW0H8)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WHEAT GERM OIL (UNII: 14C97E680P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54633-214-01	29.57 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	10/01/2014

Labeler - The Podiatree Company (078656000)