BAROX BODY CARE MASSAGE- menthol gel 
Dr.JangLab Inc.

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 ingredient: Menthol 2%

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

Image of tube

BAROX  BODY CARE MASSAGE
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55692-100
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol 2.4 mg  in 120 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55692-100-01 120 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 03/01/2012
Labeler - Dr.JangLab Inc. (688380051)
Registrant - Dr.JangLab Inc. (688380051)
Establishment
Name Address ID/FEI Business Operations
Dr.JangLab Inc. 688380051 manufacture(55692-100)

Revised: 2/2013
Document Id: ede7698b-a273-455a-b814-e0220e38a2d8
Set id: aa8120bc-3c62-43ae-81f3-e46aa66c2c8e
Version: 1
Effective Time: 20130227
 
Dr.JangLab Inc.