BAROX S 60G (camphor- synthetic, methyl salicylate, menthol gel

BAROX S 60g by

Drug Labeling and Warnings

BAROX S 60g by is a Otc medication manufactured, distributed, or labeled by Barox Co., Ltd., Tai Guk Pharm. Co., Ltd_buyeo. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BAROX S 60G 
camphor (synthetic), methyl salicylate, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55692-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 SALICYLATE	2.76 g  in 60 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.48 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
AVOCADO OIL (UNII: 6VNO72PFC1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55692-210-02	1 in 1 CARTON	08/01/2018
1	NDC: 55692-210-01	60 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/01/2018

Labeler - Barox Co., Ltd. (688380051)

Registrant - Barox Co., Ltd. (688380051)

Establishment
Name	Address	ID/FEI	Business Operations
Tai Guk Pharm. Co., Ltd_buyeo		689060246	manufacture(55692-210)