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

Uses

as a hand sanitizer when there is no water, to reduce bacteria on the skin which can cause illness. Recommended for repeated use.

Warnings

Flammable, keep away from fire or flame

For external use only

When using this product

do not use in or near the eyes, or inhale
in case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor

if a rash on irritation appear and remain at the site of contact

Keep out of reach of children.

If swallowed, get medical help right away or contact a Poison Control Center immediately.

Directions

dispense sufficient liquid to cover the hands, rub hands together briskly for 30 seconds.

Allow hands to dry.

• children under 6 years of age must be upervised when using this product.

Other information

do not store above 110 0F (43 0C). May discolor certain fabrics or substances

Inactive ingredient

Aloe (aloe barbadensis) Juice, D-alpha-tocopheryl Acetate, Glycerin, PEG, Water

Product Label

image description

BENEMAX ADVANCED HAND SANITIZER
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73700-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73700-002-01	1000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/15/2020

Labeler - Nugale Pharmaceutical Inc (202595872)

Name	Address	ID/FEI	Business Operations
Establishment
Nugale Pharmaceutical Inc		202595872	manufacture(73700-002)