SURE HAND SANITIZER- ethyl alcohol gel

Sure Hand Sanitizer by

Drug Labeling and Warnings

Sure Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sir Limited Liability Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 80% (v/v)

Purpose

Antiseptic

Use

• 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

• Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

• 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

Hydrogen peroxide 0.125% (v/v), glycerol 1.45% (v/v), boiled cold water

Package Label - Principal Display Panel

DISTRIBUTED BY:

Sure Sanitizer

Jacksonville FL

www.suresanitizer.com

Sure Sanitizer (gel):

4 FL OZ (120 mL) NDC: 80163-0001-4

1 LITER (1000 mL) NDC: 80163-0001-1

6.7 FL OZ (200 mL) NDC: 80163-0001-6

INGREDIENTS AND APPEARANCE

SURE HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80163-0001
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)	12.5 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80163-0001-4	120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/27/2020
2	NDC: 80163-0001-1	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/27/2020
3	NDC: 80163-0001-6	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/26/2020

Labeler - Sir Limited Liability Company (058941499)

Establishment
Name	Address	ID/FEI	Business Operations
Sir Limited Liability Company		058941499	manufacture(80163-0001)