Active Ingredient
Hydrogen peroxide 3%
Benemax Advanced Hand Sanitizer
FDA Label NDC 73700-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nugale Pharmaceutical Inc for the product Benemax Advanced Hand Sanitizer (NDC 73700-003). 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, purpose, warnings, uses, directions, keep out of reach of children, inactive ingredient, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Warnings
For external use only. Do not use: In the eyes over large areas of the body, or for longer than 1 week. Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.
Stop use immediately and consult your physician if: The condition persists or worsens after use. If sore mouth symptoms do not improve in 7 days, If irritation, pain or redness persist or worsen. If swelling, rash or fever develop.
Uses
First aid to help prevent the risk of infection in minor cuts, scrapes and burns. Aids in the removal of phlegm, mucous or other secretions associated with occasional sore mouth.
Directions
• clean the affected area • apply a small amount of product on affected area 1 to 3 times a day • may be covered with a sterile bandage • if
bandaged, let dry first • children under 12 years of age should be supervised in the use of this product. • children under 2 years of age: consult a dentist or doctor before use.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Inactive Ingredient
Water
Other Information
Keep tightly closed in a cool dark place • Do not shake bottle • Hold away from face when opening.
For use as an oral debriding agent (oral rinse):
Adults and children 2 years of age and over:
mix with an equal amount of water swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow.
Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
Children under 12 years should be supervised in the use of this product.
Children under 2 years of age: consult a dentist or doctor.
Product Label
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