THRITEX- menthol patch 
Binger Consulting 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.

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Thritex

Drug Facts

Active ingredient

Menthol 5.00%

Purpose

Analgesic/Counterirritant

Keep out of reach of children. Consult physician for children under 12.

Uses

• temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness

Warnings

For external use only

Do not use

• on wounds or damaged skin

• if you are allergic to Menthol

When using this product

• do not cover with bandage

• use only as directed

• avoid contact with eyes and mucous membranes

Stop use and ask a doctor if

• conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days

• rash, itching or excessive skin irritation occurs

Directions adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily

How to apply

• clean and dry affected area

• cut open pouch and remove patch

• remove protective film and apply directly to area of pain

• apply to affected area  not more than 3 times daily

• wash hands with soap after applying patch

• reseal pouch containing unused patches.

Other ingredients water, capsaicin, glycerin, sodium polyacrylate, polysorbate 80, aloe barbadensis leaf (aloe vera leaf) juice, EDTA disodium salt, diazolidinyl urea, methylparaben, iodopropynyl butylcarbamate, propylparaben

Questions or comments? call weekdays from 9 AM to 5 PM PST 888-501-5651

Other information store below 25°C (77°F), avoid direct sunlight

Packaging

label2

THRITEX 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69440-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAPSAICIN (UNII: S07O44R1ZM)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69440-008-1515 in 1 BOX01/01/2015
1100 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2015
Labeler - Binger Consulting Corporation (079635976)
Establishment
NameAddressID/FEIBusiness Operations
Active Intelligence, LLC080416593manufacture(69440-008)

Revised: 10/2021
Document Id: ff4b111d-47cb-490d-8122-af553944dc5d
Set id: 32aca040-37f7-4195-8a5f-332d589a64d8
Version: 4
Effective Time: 20211011
 
Binger Consulting Corporation