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BAROX S by Barox Co., Ltd.

Dosage form: gel
Ingredients: CAMPHOR (SYNTHETIC) 7.08g in 120g, METHYL SALICYLATE 5.52g in 120g, MENTHOL 0.96g in 120g
Labeler: Barox Co., Ltd.
NDC Code: 55692-110

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 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

BAROX S 
camphor (synthetic), methyl salicylate, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55692-110
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)7.08 g  in 120 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE5.52 g  in 120 g
MENTHOL (MENTHOL) MENTHOL0.96 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
Water 
AVOCADO OIL 
Packaging
#Item CodePackage Description
1NDC:55692-110-01120 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2014
Labeler - Barox Co., Ltd. (688380051)
Registrant - Barox Co., Ltd. (688380051)
Establishment
NameAddressID/FEIOperations
Gdkcosmetics Co., Ltd.557821946manufacture(55692-110)

Revised: 09/2017
 
Barox Co., Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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