FUNGINIX AF- tolnaftate cream

FUNGINIX AF by

Drug Labeling and Warnings

FUNGINIX AF by is a Otc medication manufactured, distributed, or labeled by The Sisquoc Healthcare Corporation, COASTAL CONTRACT PACKAGING, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

TOLNAFTATE 1%

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 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.

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 Of􀏐icinale (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 AF 
tolnaftate cream

Product 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 final	part333C	03/25/2019

Labeler - The Sisquoc Healthcare Corporation (021517142)

Establishment
Name	Address	ID/FEI	Business Operations
COASTAL CONTRACT PACKAGING, INC.		137341611	manufacture(71229-103)