MYHEALTH ALCOHOL ANTISEPTIC HAND SANITIZER- alcohol liquid

MyHealth Alcohol Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

MyHealth Alcohol Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Aeroflex Industria de Aerosol Ltda. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this productkeep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

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

Keep out of reach of children.

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

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Directions

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

Other Information

• Store between 15-30C (59-86F)
•  Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

aqua, butane, isobutane, propane, glycerin, parfum, triclosan, denatonium benzoate,butylphenyl methylpropional, linalool.

Product label

INGREDIENTS AND APPEARANCE

MYHEALTH ALCOHOL ANTISEPTIC HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80661-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTANE (UNII: 6LV4FOR43R)
SULFURYL FLUORIDE (UNII: 64B59K7U6Q)
ISOBUTANE (UNII: BXR49TP611)
PROPANE (UNII: T75W9911L6)
TRICLOSAN (UNII: 4NM5039Y5X)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80661-001-01	150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	09/26/2020

Labeler - Aeroflex Industria de Aerosol Ltda (898397347)

Establishment
Name	Address	ID/FEI	Business Operations
Aeroflex Industria de Aerosol Ltda		898397347	manufacture(80661-001)