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NDC 54633-0214-01 Fortinia 1 g/100mL Details

Fortinia 1 g/100mL

Fortinia 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: 54633-0214-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Clotrimazole Topical

Product Information

NDC	54633-0214
Product ID	54633-214_60dcd391-7bf3-9ec2-e053-2991aa0a4a17
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
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 54633-0214-01 (54633021401)

Pricing Information	N/A
NDC Package Code	54633-214-01
Billing NDC	54633021401
Package	29.57 mL in 1 BOTTLE, PLASTIC (54633-214-01)
Marketing Start Date	2014-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a003130b-77f7-4d42-8e7f-edd55176f013 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

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

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
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)

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

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

Labeler - The Podiatree Company (078656000)

Revised: 12/2017

Document Id: 60dcd391-7bf3-9ec2-e053-2991aa0a4a17

Set id: a003130b-77f7-4d42-8e7f-edd55176f013

Version: 2

Effective Time: 20171220