Barox
FDA Label NDC 55692-150

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Barox Co., Ltd. for the product Barox (NDC 55692-150). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, uses, direction, description, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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, Cetyl Palmitate, 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.

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 : [email protected]

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