HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by AHAVA Dead Sea Laboratories Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Alcohol 70% v/v

Purpose

Antiseptic

Use[s]

For hand-washing to decrease bacteria on the skin, only when water is not available

Warnings

For external use only. Flammable. Keep away from heat

Do not use

• In children less than 2 months age
• On open 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.

Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away

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 (Water), Glycerin, Propylene Glycol, Carbomer, Triethanolamine.

Questions or comments

Call toll free 1-800-366-7254

PRINCIPAL DISPLAY PANEL - 100 ml Bottle Label

Alcohol Gel
Hand Sanitizer

Alcohol Antisepctic 70%
Topical Solution

Antiseptic Hand Rub
Non-sterile Solution

100 ml ℮ 3.4 fl.oz

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-289
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)
Propylene Glycol (UNII: 6DC9Q167V3)
Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-289-28	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/20/2020
2	NDC: 60289-289-36	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/20/2020

Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)