FUNGINIX ANTI-FUNGAL TREATMENT- undecylenic acid ointment 
The Sisquoc Healthcare Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

FUNGINIX ANTI-FUNGAL TREATMENT

ACTIVE INGREDIENT

UNDECYLENIC ACID 10%

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 Offi cinale (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 Label

Funginix Insert

FUNGINIX ANTI-FUNGAL TREATMENT 
undecylenic acid ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71229-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID10 g  in 100 mL
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71229-102-1130 mL 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 finalpart333C03/25/2019
Labeler - The Sisquoc Healthcare Corporation (021517142)
Establishment
NameAddressID/FEIBusiness Operations
COASTAL CONTRACT PACKAGING, INC.137341611manufacture(71229-102)

Revised: 1/2020
Document Id: 94d6bf24-fc6e-4203-99c4-cf602f32d7b5
Set id: 92db5433-5a1b-4cb9-b8eb-217c2a807a99
Version: 4
Effective Time: 20200102
 
The Sisquoc Healthcare Corporation