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NDC 54633-0017-01 Fortinia OF 1 g/100mL Details

Fortinia OF 1 g/100mL

Fortinia OF is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by The Podiatree Company. The primary component is CLOTRIMAZOLE.

MedlinePlus Drug Summary

Topical clotrimazole is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Clotrimazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.

Related Packages: 54633-0017-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Clotrimazole Topical

Product Information

NDC	54633-0017
Product ID	54633-017_60cb962b-0e2d-105a-e053-2a91aa0a040e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Fortinia OF
Proprietary Name Suffix	n/a
Non-Proprietary Name	clotrimazole 1%
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100mL
Substance Name	CLOTRIMAZOLE
Labeler Name	The Podiatree Company
Pharmaceutical Class	Azole Antifungal [EPC], Azoles [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333C
Listing Certified Through	2024-12-31

Package

Package Images

NDC 54633-0017-01 (54633001701)

Pricing Information	N/A
NDC Package Code	54633-017-01
Billing NDC	54633001701
Package	29.57 mL in 1 BOTTLE, GLASS (54633-017-01)
Marketing Start Date	2017-07-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 60cbd3aa-9ad7-24e4-e053-2a91aa0ab05f Details

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

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

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

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

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

Labeler - The Podiatree Company (078656000)

Revised: 12/2017

Document Id: 60cb962b-0e2d-105a-e053-2a91aa0a040e

Set id: 60cbd3aa-9ad7-24e4-e053-2a91aa0ab05f

Version: 2

Effective Time: 20171220