Label: FUNGINIX ANTI-FUNGAL TREATMENT- undecylenic acid ointment
- NDC Code(s): 71229-102-11
- Packager: The Sisquoc Healthcare Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 27, 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 most ringworm (tinea corporis) and athlete’s foot (tinea pedis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation and discomforts which may accompany these conditions.
- Clean the affected area with soap and warm water and dry thoroughly. Apply a thin layer of FUNGINIX over the affected area twice daily (morning and night), or as directed by a physician. Allow 3-5 minutes for the solution to penetrate the skin and absorb fully into the surrounding tissue.
- FUNGINIX should be applied to cuticles, around nail edges and under nail tips where reachable with the applicator brush. This product is not intended to, nor will it, penetrate hard nail surfaces.
- For athlete’s foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes and change shoes and socks at least once daily. For athlete’s foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
- Intended for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
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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 Offi cinale (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 ANTI-FUNGAL TREATMENT
undecylenic acid ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71229-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 10 g in 100 mL 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) LAVENDER OIL (UNII: ZBP1YXW0H8) JASMINUM OFFICINALE WHOLE (UNII: X3314B4SYD) CLOVE OIL (UNII: 578389D6D0) COCOA BUTTER (UNII: 512OYT1CRR) ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T) 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:71229-102-11 30 mL 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)
