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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

Barox Co., Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: Topical Analgesic 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.

Authorization status:

OTC monograph not final

Summary of Product characteristics

BAROX S- 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, 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.
US ES
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 : [e-mail]
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
BAROX S
camphor (synthetic), methyl salicylate, menthol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:556 9 2-110
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -
UNII:5TJD8 2A1ET)
CAMPHOR
(SYNTHETIC)
7.0 8 g
in 120 g
METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID -
UNII:O414PZ4LPZ)
METHYL SALICYLATE
5.52 g in 12