TIESO RAPIDO- menthol, benzalkonium chloride cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
ANDIVA Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final
Authorization number:
73184-0080-1

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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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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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7318 4-0 0 8 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

0 .0 8 g

in 8 0 mL

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .0 32 g

in 8 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

GLYCERYL TRIO LEATE (UNII: O0 5EC6 26 6 3)

LEPIDIUM MEYENII RO O T (UNII: HP7119 212T)

1,2 -HEXANEDIO L (UNII: TR0 46 Y3K1G)

GLYCERIN (UNII: PDC6 A3C0 OX)

XYLITYLGLUCO SIDE (UNII: O0 IEZ16 6 FB)

SO RBITAN MO NO STEARATE (UNII: NVZ4I0 H58 X)

ANHYDRO XYLITO L (UNII: 8 XWR7NN42F)

ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)

TRO METHAMINE (UNII: 0 23C2WHX2V)

ANHYDRO US DEXTRO SE (UNII: 5SL0 G7R0 OK)

CAPRYLYL TRISILO XANE (UNII: Q9 5M2P1KJL)

METHYL GLUCO SE SESQ UISTEARATE (UNII: V1YW10 H14D)

PURSLANE (UNII: M6 S8 40 WXG5)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

XYLITO L (UNII: VCQ0 0 6 KQ1E)

CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

Packag ing

ANDIVA Inc.

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:7318 4-0 0 8 0 -

1 in 1 BOX

0 9 /10 /20 19

1

8 0 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 9 /10 /20 19

Labeler -

ANDIVA Inc. (695032533)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ATEC CO., LTD.

6 8 9 276 6 8 1

ma nufa c ture (7318 4-0 0 8 0 )

Revised: 11/2020

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