Active Ingredient
Active ingredient: Menthol 2.5%
Barox
FDA Label NDC 52227-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ktaiga Co., Ltd. for the product Barox (NDC 52227-100). 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, dosage and administration, description, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive ingredients:
Water, Alcohol, Propylene Glycol, Germanium Dioxide, Allantoin, Carbomer, Triethanolamine, PEG-60 Hydrogenated Castor Oil, Disodium EDTA, Methylparaben
Purpose
Purpose: Topical Analgesic
Warnings
Warnings: For external use only
Keep Out Of Reach Of Children
Keep out of reach of children:
Keep out of reach of children to avoid accidental ingestion.
If swallowed, get medical help or contact a Poison Control Center immediately.
Uses
Uses:
Temporarily relieves the minor pains of muscles and joints associated with:
simple backache and arthritis
Dosage And Administration
Dosage and administration:
adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor
Description
Ask a doctor before use if you have redness over the affected area.
Do not use: on wounds or damaged skin
Stop use and ask a doctor if excessive skin irritation occurs.
Other information:
Store in a cool dry place with lid closed tightly
Question
Contact: [email protected]
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