FORTINIA- clotrimazole cream

Fortinia by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - The Podiatree Company (078656000)

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