BAROX by KTAIGA CO., LTD. BAROX- menthol gel

BAROX by

Drug Labeling and Warnings

BAROX by is a Otc medication manufactured, distributed, or labeled by KTAIGA CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Active ingredient: Menthol 2.5%

Inactive ingredient

Inactive ingredients:
Water, Alcohol, Propylene Glycol, Germanium Dioxide, Allantoin, Carbomer, Triethanolamine, PEG-60 Hydrogenated Castor Oil, Disodium EDTA, Methylparaben

Purpose

Purpose: Topical Analgesic

Warnings

Warnings: For external use only

Keep out of reach of children

Keep out of reach of children:
Keep out of reach of children to avoid accidental ingestion.
If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

Uses:
Temporarily relieves the minor pains of muscles and joints associated with:
simple backache and arthritis

Dosage and administration

Dosage and administration:
adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor

Description

Ask a doctor before use if you have redness over the affected area.

Do not use: on wounds or damaged skin

Stop use and ask a doctor if excessive skin irritation occurs.

Other information:
Store in a cool dry place with lid closed tightly

Question
Contact: smyou2@nate.com

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BAROX 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52227-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	82.2 g  in 120 mL
ALCOHOL (UNII: 3K9958V90M)	18 g  in 120 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	4.8 g  in 120 mL
GERMANIUM DIOXIDE (UNII: 5O6CM4W76A)	0.96 g  in 120 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.6 g  in 120 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52227-100-01	120 mL in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2012

Labeler - KTAIGA CO., LTD. (557819324)

Registrant - KTAIGA CO., LTD. (557819324)

Establishment
Name	Address	ID/FEI	Business Operations
KTAIGA CO., LTD.		557819324	manufacture(52227-100)