[de-listing] TIESO RAPIDO

TIESO RAPIDO by

Drug Labeling and Warnings

TIESO RAPIDO 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 RAPIDO- menthol, benzalkonium chloride cream 
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 RAPIDO

Active Ingredients Purposes

Menthol 0.1 %.....................................external analgesic
Benzalkonium chloride 0.04 %...........antibacterial

Inactive ingredients

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

TIESO RAPIDO 
menthol, benzalkonium chloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73184-0080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.08 g  in 80 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.032 g  in 80 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73184-0080-1	1 in 1 BOX	09/10/2019
1		80 mL in 1 CONTAINER; 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	part333A	09/10/2019	10/22/2021

Labeler - ANDIVA Inc. (695032533)

Establishment
Name	Address	ID/FEI	Business Operations
ATEC CO., LTD.		689276681	manufacture(73184-0080)

Revised: 10/2021

Document Id: ceea01a2-e6fb-9948-e053-2995a90a9e26

34390-5

Set id: b4c2a81b-c0aa-50b6-e053-2a95a90a4d7a

Version: 2

Effective Time: 20211022