FLORIDA LABORATORIES - HAND SANITIZER- ethyl alcohol solution

Florida Laboratories - Hand Sanitizer by

Drug Labeling and Warnings

Florida Laboratories - Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Florida Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 80 % v/v

Purpose

Antiseptic

Uses

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

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 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 Poison Control Center right away (1-800-222-1222).

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

glycerin, hydrogen peroxide, purified water USP

SPL UNCLASSIFIED SECTION

Alcohol Antiseptic 80%

Topical Solution

Non-sterile Solution

DISTRIBUTED BY:

Florida Laboratories Inc, Fort Lauderdale, FL 33309

www.flalab.com

Packaging

INGREDIENTS AND APPEARANCE

FLORIDA LABORATORIES - HAND SANITIZER 
ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78213-100
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78213-100-03	68 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2020
2	NDC: 78213-100-01	940 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2020
3	NDC: 78213-100-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/25/2020

Labeler - Florida Laboratories, Inc. (080216309)