Guardex Hand Sanitizer Antiseptic Solution

Manufacturer: Guardex Labs, Inc.
Effective date: 2020-09-03
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:26:49

Label at a glance#

ProductGuardex Hand Sanitizer Antiseptic Solution

Active ingredientISOPROPYL ALCOHOL

Label structure12 sections

Indications and uses

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

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

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

On children less than 2 months of age

On open skin wounds

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

If irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTHER SAFETY INFORMATION

-Store between 15-30C (59-86F).

-Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, Triethanolamine, carbomer, purified water USP

Guardex Hand Sanitizer Antiseptic Topical Solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1039900	isopropyl alcohol 75 % Topical Solution	PSN	1
1039900	isopropyl alcohol 0.75 ML/ML Topical Solution	SCD	1
1039900	isopropyl alcohol 75 % Topical Solution	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80307-002-04	2021-07-23	C162847	48780-1	c7ccaba7-1185-fd44-e053-dadaa90aa01b	Guardex Hand Sanitizer Antiseptic Topical Solution
80307-002-08	2021-07-23	C162847	48780-1	c7ccaba7-1185-fd44-e053-dadaa90aa01b	Guardex Hand Sanitizer Antiseptic Topical Solution
80307-002-16	2021-07-23	C162847	48780-1	c7ccaba7-1185-fd44-e053-dadaa90aa01b	Guardex Hand Sanitizer Antiseptic Topical Solution
80307-002-33	2021-07-23	C162847	48780-1	c7ccaba7-1185-fd44-e053-dadaa90aa01b	Guardex Hand Sanitizer Antiseptic Topical Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80307-002-04	Guardex Hand Sanitizer Antiseptic Solution	118 mL in 1 BOTTLE	LIQUID	118	1
80307-002-08	Guardex Hand Sanitizer Antiseptic Solution	250 mL in 1 BOTTLE	LIQUID	250	1
80307-002-16	Guardex Hand Sanitizer Antiseptic Solution	500 mL in 1 BOTTLE	LIQUID	500	1
80307-002-33	Guardex Hand Sanitizer Antiseptic Solution	1000 mL in 1 BOTTLE	LIQUID	1000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80307-002	GUARDEX HAND SANITIZER ANTISEPTIC SOLUTION (ISOPROPYL ALCOHOL 75%) LIQUID [GUARDEX LABS, INC.]	1	Legacy NDC, 4 package rows	20200904_ae6d6c48-f9a8-5add-e053-2995a90a4eea.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Guardex Hand Sanitizer Antiseptic Solution
Isopropyl Alcohol 75%
TRIETHANOLAMINE TRISTEARATE
HYDROGEN PEROXIDE
GLYCERIN
ISOPROPYL ALCOHOL
WATER
(3-BROMOPROPYL)BENZENE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80307-002	80307-002-08, 80307-002-04, 80307-002-16, 80307-002-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TRIETHANOLAMINE TRISTEARATE	HOM72YRP1F	IACT
HYDROGEN PEROXIDE	BBX060AN9V	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOPROPYL ALCOHOL	ND2M416302	ACTIB
WATER	059QF0KO0R	IACT
(3-BROMOPROPYL)BENZENE	6VX623QN9V	IACT

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
ae6d66cc-4e8b-479a-e053-2a95a90abc12			ae6d6c48-f9a8-5add-e053-2995a90a4eea	2020-09-03	Warnings	Exact identifier spl id: ae6d66cc-4e8b-479a-e053-2a95a90abc12 spl set id: ae6d6c48-f9a8-5add-e053-2995a90a4eea

Reported adverse events (FAERS/openFDA)#

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