BAROX MASSAGE- menthol gel
Barox Co., Ltd.

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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ACTIVE INGREDIENT

Active ingredients: Menthol 2.5%

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Alcohol, Propylene Glycol, 1,2-Hexanediol, Carbomer, Polysorbate 20, Tromethamine, Dendropanax Morbifera Extract, Allantoin, Ethylhexylglycerin, Disodium EDTA, Dimethyl Sulfone, Centella Asiatica Extract, Nelumbo Nucifera Callus Culture Extract, Chitosan, Sodium Chondroitin Sulfate, CI 42090

PURPOSE

Purpose: Topical Analgesic

WARNINGS

Warnings:
For external use only. Avoid contact with eyes. Keep this and all drugs out of the reach of children.

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children.

Uses

Uses:

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

Direction

Direction:

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 d doctor

QUESTIONS

Questions
www.barox.co.kr

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

BAROX MASSAGE
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55692-220
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.5 g in 60 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55692-220-02	1 in 1 CARTON	09/01/2018	03/01/2019
1	NDC:55692-220-01	60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/01/2018	03/01/2019

Labeler - Barox Co., Ltd. (688380051)

Registrant - Barox Co., Ltd. (688380051)

Name	Address	ID/FEI	Business Operations
Establishment
Gdk cosmetics Co., Ltd.		557821946	manufacture(55692-220)

Revised: 11/2019

Document Id: 1ee1e604-669f-449b-af62-a74e7ed03292

Set id: 5a893860-6109-4082-8d5c-40c7f9d173a8

Version: 3

Effective Time: 20191107

Barox Co., Ltd.