FUNGINIX AF- tolnaftate cream 
The Sisquoc Healthcare Corporation

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Sisquoc HC (as PLD) - FUNGINIX AF ATHLETE'S FOOT CREAM (71229-103)

ACTIVE INGREDIENT

TOLNAFTATE 1%

PURPOSE

ANTIFUNGAL

USES

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. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

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

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

Funginix AF Label

Funginix AF Insert

FUNGINIX AF 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71229-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71229-103-1128 g in 1 TUBE; Type 0: Not a Combination Product03/25/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00503/25/2019
Labeler - The Sisquoc Healthcare Corporation (021517142)

Revised: 10/2023
Document Id: 0906fc2c-0620-c21e-e063-6394a90ad75c
Set id: f6cf5315-6678-486c-85b2-d4b3f748600e
Version: 6
Effective Time: 20231031
 
The Sisquoc Healthcare Corporation