BENEMAX ADVANCED HAND SANITIZER- hydrogen peroxide liquid 
Nugale Pharmaceutical Inc

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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Drug Facts

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

image description

BENEMAX ADVANCED HAND SANITIZER 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73700-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73700-003-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/25/2021
Labeler - Nugale Pharmaceutical Inc (202595872)
Establishment
NameAddressID/FEIBusiness Operations
Nugale Pharmaceutical Inc202595872manufacture(73700-003)

Revised: 3/2021
Document Id: bd49f19e-5cff-4175-e053-2995a90a0d12
Set id: 8faf0d37-86e8-4829-a778-f934e4927b5e
Version: 1
Effective Time: 20210311
 
Nugale Pharmaceutical Inc