BENEMAX ADVANCED HAND SANITIZER- isopropyl alcohol 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

Isopropyl alcohol 70%, USP

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use
on children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In
case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may
be signs of a serious condition.

Directions

• Place enough product on hands or affected area to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Uses

Antiseptic and Hand Sanitizer to help reduce bacteria that may cause disease. For use when soap & water are unavailable.

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

Store between 15 °C and 30 °C. Avoid freezing and excessive heat above 400 °C (104 °F)

Product label

image description

BENEMAX ADVANCED HAND SANITIZER 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73700-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73700-004-01473 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(73700-004)

Revised: 3/2021
Document Id: bd4a0377-7e06-bd07-e053-2a95a90a339c
Set id: bcd68601-d56d-4d94-89f8-0d18be6288d7
Version: 1
Effective Time: 20210311
 
Nugale Pharmaceutical Inc