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Fortinia by The Podiatree Company

Medically reviewed on December 19, 2017

Dosage form: cream
Ingredients: CLOTRIMAZOLE 10mg in 1g
Labeler: The Podiatree Company
NDC Code: 54633-314

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

FORTINIA 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54633-314
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYL L-ARGININE 
OLIVE OIL 
PANTHENOL 
PETROLATUM 
STEARYL ALCOHOL 
TROLAMINE 
UREA 
AVOCADO OIL 
SODIUM HYDROXYMETHYLGLYCINATE 
TITANIUM DIOXIDE 
DIMETHICONE 1000 
ALOE VERA LEAF 
SHEA BUTTER 
GLYCERIN 
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE 
WATER 
CETYL ALCOHOL 
HYDROLYZED JOJOBA ESTERS (ACID FORM) 
STEARIC ACID 
Packaging
#Item CodePackage Description
1NDC:54633-314-8080 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/02/2015
Labeler - The Podiatree Company (078656000)
Establishment
NameAddressID/FEIOperations
EMS Contract Packaging048602791manufacture(54633-314)

 
The Podiatree Company

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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