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

BAROX S by

Drug Labeling and Warnings

BAROX S by is a Otc medication manufactured, distributed, or labeled by Barox Co., Ltd., Gdkcosmetics Co., Ltd.. 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, Carbomer, Ethanol, Methyl Sulfonylmethane, Methyl Parahydroxybenzoate, Cetyl Palmitate, Avocado Oil, Polysorbate 80, Cetyl Alcohol, Aminomethyl Propanol

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 intented 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.

DESCRIPTION

DESCRIPTION:

Do not use : on wounds or damage skin

Stop use and ask a doctor Stop use and ask a doctor if excessive skin irritation occurs. Ask a doctor before use if you have redness over the affected area

Other Information : Store in a cool dry place with lid closed tightly

Question Contact : jhs3840@naver.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55692-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	7.08 g  in 120 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	5.52 g  in 120 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.96 g  in 120 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: 55692-110-01	120 g in 1 CARTON; Type 0: Not a Combination Product	03/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2014

Labeler - Barox Co., Ltd. (688380051)

Registrant - Barox Co., Ltd. (688380051)

Establishment
Name	Address	ID/FEI	Business Operations
Gdkcosmetics Co., Ltd.		557821946	manufacture(55692-110)