HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Brady Industries, Inc., McKenna Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 65% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from fire and flame.

Do not use

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

WHEN USING

When using this product avoid contact with eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Put enought on your palm to cover hand and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using the product.

Other information

• Store between 20-25C (68-77F)
• May discolor some fabrics or surfaces
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Glycerin, Propylene Glycol, Carbomer, Fragrance, Isopropyl Palmitate, Aminomethyl Propanol, Tocopheryl Acetate.

Package Label - Principal Display Panel

946ml NDC: 79258-104-32

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79258-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER 934 (UNII: Z135WT9208)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79258-104-32	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/30/2020

Labeler - Brady Industries, Inc. (034932657)

Establishment
Name	Address	ID/FEI	Business Operations
McKenna Labs, Inc.		090631412	manufacture(79258-104)