BENEMAX ADVANCED HAND SANITIZER- hydrogen peroxide liquid

BENEMAX ADVANCED Hand Sanitizer by

Drug Labeling and Warnings

BENEMAX ADVANCED Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Nugale Pharmaceutical Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Hydrogen peroxide 3%

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

INGREDIENTS AND APPEARANCE

BENEMAX ADVANCED HAND SANITIZER 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73700-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	3 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73700-003-01	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/25/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/25/2021

Labeler - Nugale Pharmaceutical Inc (202595872)

Establishment
Name	Address	ID/FEI	Business Operations
Nugale Pharmaceutical Inc		202595872	manufacture(73700-003)