[de-listing] TIESO FOOT (Foot spray) : 69978-0169-1

TIESO FOOT by

Drug Labeling and Warnings

TIESO FOOT by is a Otc medication manufactured, distributed, or labeled by ANDIVA Inc., ATEC Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TIESO FOOT- benzalkonium chloride, menthol spray 
ANDIVA Inc.

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.

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[de-listing] TIESO FOOT (Foot spray) : 69978-0169-1

Active ingredients Purposes

Benzalkonium chloride 0.04%..........Antibacterial
Menthol 0.1%.....................................Antipruritic

Inactive ingredients Water, Alcohol, Ethylhexyl
Stearate, Triolein, Lepidium Meyenii Root Extract,
1,2-Hexanediol, Caprylyl Methicone, Glycerin,
Fragrance, Glyceryl Dioleate, Methyl Glucose
Sesquistearate, Portulaca Oleracea Extract,
Xylitylglucoside, Acrylates/Beheneth-25
Methacrylate Copolymer, Sorbitan Stearate,
Anhydroxylitol, Butylene Glycol, Xylitol, Carbomer,
Disodium EDTA, Tromethamine, Glucose

TIESO FOOT 
benzalkonium chloride, menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73184-0169
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.05 g  in 50 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.02 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
LEPIDIUM MEYENII ROOT (UNII: HP7119212T)
GLYCERIN (UNII: PDC6A3C0OX)
PURSLANE (UNII: M6S840WXG5)
ALCOHOL (UNII: 3K9958V90M)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
XYLITOL (UNII: VCQ006KQ1E)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROMETHAMINE (UNII: 023C2WHX2V)
BEHENETH-25 (UNII: 0G17KJ5M7P)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
GLYCERYL TRIOLEATE (UNII: O05EC62663)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERYL DIOLEATE (UNII: Z3MP1W91CW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73184-0169-1	1 in 1 BOX	08/07/2020
1		50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/07/2020	10/22/2021

Labeler - ANDIVA Inc. (695032533)

Establishment
Name	Address	ID/FEI	Business Operations
ATEC Co., Ltd.		689276681	manufacture(73184-0169)

Revised: 10/2021

Document Id: ceea1d4d-4d24-3acf-e053-2a95a90ac2c0

34390-5

Set id: b4c2a81b-c0bf-50b6-e053-2a95a90a4d7a

Version: 2

Effective Time: 20211022