Sure Hand Sanitizer

Manufacturer: Sir Limited Liability Company
Effective date: 2021-11-10
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:44:51

Label at a glance#

ProductSure Hand Sanitizer

Active ingredientALCOHOL

Label structure12 sections

Dosage and administration

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.

Storage and handling

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

Contacts and useful links#

Websitewww.suresanitizer.com

www.suresanitizer.com

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% (v/v)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package Label - Principal Display Panel

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

120

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

1000

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

200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1041498	ethanol 80 % Topical Gel	PSN	3
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	3
1041498	ethanol 80 % Topical Gel	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80163-0001-1	2023-01-30	C162847	48780-1	f386c64a-234f-0266-e053-dadaa90a7c1a	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
80163-0001-4	2023-01-30	C162847	48780-1	f386c64a-234f-0266-e053-dadaa90a7c1a	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
80163-0001-6	2023-01-30	C162847	48780-1	f386c64a-234f-0266-e053-dadaa90a7c1a	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80163-0001-1	Sure Hand Sanitizer	1000 mL in 1 BOTTLE, PUMP	GEL	1000	3
80163-0001-4	Sure Hand Sanitizer	120 mL in 1 BOTTLE, PUMP	GEL	120	3
80163-0001-6	Sure Hand Sanitizer	200 mL in 1 BOTTLE, PUMP	GEL	200	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80163-0001	SURE HAND SANITIZER (ETHYL ALCOHOL) GEL [SIR LIMITED LIABILITY COMPANY]	3	Legacy NDC, 3 package rows	20211111_adc9efbb-6600-596e-e053-2a95a90a0835.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Sure Hand Sanitizer
ETHYL ALCOHOL
GLYCERIN
HYDROGEN PEROXIDE
WATER
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80163-0001	80163-0001-4, 80163-0001-1, 80163-0001-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
HYDROGEN PEROXIDE	BBX060AN9V	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d070f686-4ca3-55d1-e053-2995a90af638			adc9efbb-6600-596e-e053-2a95a90a0835	2021-11-10	Warnings	Exact identifier spl id: d070f686-4ca3-55d1-e053-2995a90af638 spl set id: adc9efbb-6600-596e-e053-2a95a90a0835

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.