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NDC 54633-0314-80 Fortinia 10 mg/g Details

Fortinia 10 mg/g

Fortinia is a TOPICAL CREAM 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: 54633-0314-80
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Clotrimazole Topical

Product Information

NDC	54633-0314
Product ID	54633-314_60ba7ee8-7134-c6bb-e053-2a91aa0ac466
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
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/g
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 54633-0314-80 (54633031480)

Pricing Information	N/A
NDC Package Code	54633-314-80
Billing NDC	54633031480
Package	80 g in 1 BOTTLE, PUMP (54633-314-80)
Marketing Start Date	2015-02-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 60ba6f8a-8617-d4f6-e053-2991aa0a4a71 Details

SPL UNCLASSIFIED SECTION

Drug Facts

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 if

irritation occurs
there is no improvement within 4 weeks

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wash affected area and dry thoroughly
apply a thin layer to the affected area twice daily (morning and night)
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 socks at least once daily
for athlete's foot and ringworm, use daily for 4 weeks
if condition persists longer, consult your doctor
this product is not effective on the scalp or nails

Other information

Store at controlled room temperature

Questions or Suggestions?

1.855.763.8733 or visit us at www.thepodiatreecompany.com. Our commitment to you is 100% satisfaction. If you are not

completely satisfied, please contact us directly for a full refund.

Inactive ingredients

Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea Butter), Caprylic/Capric Triglyceride, Cetyl Alcohol, Dimethicone, Fragrance, Glycerin, L-Arginine, Olea Europaea (Olive) Fruit Oil, Panthenol, Persia Gratissima (Avocado) Oil, Petrolatum, Simmondsia Chinensis (Jojoba) Esters, Stearic Acid, Stearyl Alcohol, Sodium Hydroxymethylglycinate, Titanium Dioxide, Triethanolamine, Urea (20%), Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FORTINIA

clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54633-314
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
METHYL L-ARGININE (UNII: W6957UBY9Z)
OLIVE OIL (UNII: 6UYK2W1W1E)
PANTHENOL (UNII: WV9CM0O67Z)
PETROLATUM (UNII: 4T6H12BN9U)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)
UREA (UNII: 8W8T17847W)
AVOCADO OIL (UNII: 6VNO72PFC1)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIMETHICONE 1000 (UNII: MCU2324216)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54633-314-80	80 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/02/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	02/02/2015

Labeler - The Podiatree Company (078656000)

Name	Address	ID/FEI	Business Operations
Establishment
EMS Contract Packaging		048602791	manufacture(54633-314)

Revised: 12/2017

Document Id: 60ba7ee8-7134-c6bb-e053-2a91aa0ac466

Set id: 60ba6f8a-8617-d4f6-e053-2991aa0a4a71

Version: 3

Effective Time: 20171219