BAROX BODY CARE MASSAGE RELAX REFRESH REVITAL- 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.

----------

ACTIVE INGREDIENT

Active ingredient: 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

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

Description

- Do not use: on wounds or damaged skin

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

- 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 : jhs3840@naver.com

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

BAROX BODY CARE MASSAGE RELAX REFRESH REVITAL
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55692-200
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55692-200-01	120 mL in 1 CARTON; Type 0: Not a Combination Product	04/01/2014	03/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/01/2014	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(55692-200)

Revised: 11/2019

Document Id: df6d82f1-ab28-48f2-859b-e77afa0068e0

Set id: 1d2cf507-c3c6-400b-98e2-91d2eb03ff58

Version: 4

Effective Time: 20191107

Barox Co., Ltd.