Label: FORTINIA- clotrimazole cream
- NDC Code(s): 54633-314-80
- Packager: The Podiatree Company
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated December 19, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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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
- Questions or Suggestions?
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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
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INGREDIENTS AND APPEARANCE
FORTINIA
clotrimazole creamProduct 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)