Label: FUNGINIX JOCK ITCH TREATMENT- tolnaftate cream
- NDC Code(s): 71229-104-11
- Packager: The Sisquoc Healthcare Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 31, 2023
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- Official Label (Printer Friendly)
- 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 jock itch. 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 Jock Itch Treatment 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 jock itch infections will require at least 2 weeks of continuous daily treatment before the infection is completely eliminated.
- Proper use of FUNGINIX Jock Itch Treatment should eliminate all types of fungal 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 Oficinale (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 JOCK ITCH TREATMENT
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71229-104 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) 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) COCOA BUTTER (UNII: 512OYT1CRR) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71229-104-11 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)
