Label: FUNGINIX AF- tolnaftate cream
- NDC Code(s): 71229-103-11
- Packager: The Sisquoc Healthcare Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 31, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- USES
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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 THE EYES. IF CONTACT OCCURS, RINSE THE EYES VERY THOROUGHLY WITH WATER.
STOP USE AND ASK A DOCTOR IF IRRITATION OCCURS OR THERE IS NO IMPROVEMENT WITHIN 4 WEEKS.
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
- For the cure of all forms of athlete’s foot (tinea pedis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation and discomforts which may accompany these conditions.
- Wash affected area and dry thoroughly. Apply a layer of FUNGINIX AF over the affected area twice daily (morning and night). Allow the cream to dry for at least 3 minutes before covering the affected area with clothing.
- Wash hands after each application to prevent the chance of the infection spreading to other parts of the skin.
- Most athlete’s foot infections will require at least 2 weeks of continuous daily treatment before the infection is completely eliminated.
- Proper use of FUNGINIX AF should eliminate all types of athlete’s foot infections. If the condition persists longer, contact a physician or medical professional.
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INACTIVE INGREDIENTS
Water, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Oleth-10 Phosphate, Triethanolamine, Polysorbate 20, Acrylates Copolymer, Glycerin,
Propylene Glycol, Uva Ursi (Bearberry) Extract, Beta-Glucan, Propolis Extract, Aloe Barbadensis Juice, Tocopheryl Acetate (Vitamin E), Camphor, Menthol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Jasminum Officinale (Jasmine) Oil, Eugenia Caryophyllus (Clove) Flower Oil, Theobroma Cacao (Cocoa) Seed Butter, Rosa Canina (Rose Hip) Flower Oil, Cetyl Hydroxyethylcellulose, Ethylhexylglycerin, Phenoxyethanol - STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FUNGINIX AF
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71229-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALMOND OIL (UNII: 66YXD4DKO9) OLETH-10 PHOSPHATE (UNII: Q95361F4VS) TROLAMINE (UNII: 9O3K93S3TK) POLYSORBATE 20 (UNII: 7T1F30V5YH) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ARCTOSTAPHYLOS UVA-URSI WHOLE (UNII: 37SXO36KR7) OAT (UNII: Z6J799EAJK) PROPOLIS WAX (UNII: 6Y8XYV2NOF) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) THEOBROMA CACAO WHOLE (UNII: EB048G1S9J) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) CAMPHOR OIL (UNII: 75IZZ8Y727) MENTHOL (UNII: L7T10EIP3A) TEA TREE OIL (UNII: VIF565UC2G) LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L) JASMINUM OFFICINALE WHOLE (UNII: X3314B4SYD) CLOVE LEAF OIL (UNII: VCA5491KVF) CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71229-103-11 28 g in 1 TUBE; Type 0: Not a Combination Product 03/25/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 03/25/2019 Labeler - The Sisquoc Healthcare Corporation (021517142)