FUNGINIX ANTI-FUNGAL TREATMENT- undecylenic acid ointment

FUNGINIX ANTI-FUNGAL TREATMENT by

Drug Labeling and Warnings

FUNGINIX ANTI-FUNGAL TREATMENT by is a Otc medication manufactured, distributed, or labeled by The Sisquoc Healthcare Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

UNDECYLENIC ACID 10%

PURPOSE

ANTIFUNGAL

USES

• ANTI-FUNGAL TREATMENT

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

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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 􀏐itting, 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.

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

Store between 20°c to 25°C (68° to 77°F)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGINIX ANTI-FUNGAL TREATMENT 
undecylenic acid ointment

Product 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 final	part333C	03/25/2019

Labeler - The Sisquoc Healthcare Corporation (021517142)

Establishment
Name	Address	ID/FEI	Business Operations
COASTAL CONTRACT PACKAGING, INC.		137341611	manufacture(71229-102)