BAROX S 60G- camphor (synthetic), methyl salicylate, 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: L-menthol 0.8%, DL-Camphor 5.9%, Methyl Salicylate 4.6%

INACTIVE INGREDIENT

Inactive Ingredients: Purified Water, Ethanol, Avocado Oil, CetylPalmitate, Polysorbate 80, Cetanol, Dimethyl Sulfone, Carbomer940, Aminomethyl Propanol, Methyl Parahydroxybenzoate, Chitosan, Emu oil, 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:
Barox S is an anti-inflammatory pain relieving and topical analgesic ointment that is intended to relieve muscle and joint pain associated with arthritis, rheumatalgia, backaches, knee pain, shoulder pain.

Direction

Direction:
Use only as directed. Adults and Children 12 Years of Age and Older: Apply to affected area not more than 3 to 4 times daily.

QUESTIONS

Questions
www.barox.co.kr

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

BAROX S 60G 
camphor (synthetic), methyl salicylate, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55692-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.54 g  in 60 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE2.76 g  in 60 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.48 g  in 60 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55692-210-021 in 1 CARTON08/01/2018
1NDC:55692-210-0160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2018
Labeler - Barox Co., Ltd. (688380051)
Registrant - Barox Co., Ltd. (688380051)
Establishment
NameAddressID/FEIBusiness Operations
Tai Guk Pharm. Co., Ltd_buyeo689060246manufacture(55692-210)

Revised: 9/2018
Document Id: 79c310bb-95cd-4d23-8bd4-454eb6d555bd
Set id: a0754435-97f4-4a6d-8cf0-ff6e62d93bc7
Version: 1
Effective Time: 20180914
 
Barox Co., Ltd.