Thritex by Binger Consulting Corporation / Active Intelligence, LLC THRITEX- menthol patch

Thritex by

Drug Labeling and Warnings

Thritex by is a Otc medication manufactured, distributed, or labeled by Binger Consulting Corporation, Active Intelligence, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Menthol 5.00%

Purpose

Analgesic/Counterirritant

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

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

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

STORAGE AND HANDLING

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

Packaging

INGREDIENTS AND APPEARANCE

THRITEX 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69440-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69440-008-15	15 in 1 BOX	01/01/2015
1		100 g in 1 PATCH; 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	part348	01/01/2015

Labeler - Binger Consulting Corporation (079635976)

Establishment
Name	Address	ID/FEI	Business Operations
Pocono Coated Products, LLC		362785771	manufacture(69440-008)