FDA.reportPublic FDA data

Guard Hand Sanitizing Gel

Manufacturer
Guard Products Inc | Custom Blenders
Effective date
2020-07-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:21:35

Label at a glance#

ProductGuard Hand Sanitizing Gel
Active ingredientALCOHOL
Label structure13 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)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

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

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.

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

glycerin, aloe vera,vitamin e acetate,carbomer, purified water USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[undefined] .473 L NDC: 77668-003-16 16 oz16 oz

[undefined] .236 L NDC: 77668-003-08

08 oz08 oz

[undefined] .946 L NDC: 77668-003-32

32 oz32 oz

[undefined] 18.9 L NDC: 77668-003-05

5 gal5 gal

[undefined] .118 L NDC: 77668-003-04 4 oz4 oz

[undefined] 208.2 L NDC: 77668-003-55

55g55g

[undefined] 1041 L NDC: 77668-003-27

totetote

[undefined] 3.785 L NDC: 77668-003-10

1 gal1 gal

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77668-003-042022-01-28C16284748780-1d6a99b39-c561-a426-e053-dadaa90af4c2Guard Hand Sanitizing Gel
77668-003-052022-01-28C16284748780-1d6a99b39-c561-a426-e053-dadaa90af4c2Guard Hand Sanitizing Gel
77668-003-082022-01-28C16284748780-1d6a99b39-c561-a426-e053-dadaa90af4c2Guard Hand Sanitizing Gel
77668-003-102022-01-28C16284748780-1d6a99b39-c561-a426-e053-dadaa90af4c2Guard Hand Sanitizing Gel
77668-003-162022-01-28C16284748780-1d6a99b39-c561-a426-e053-dadaa90af4c2Guard Hand Sanitizing Gel
77668-003-272022-01-28C16284748780-1d6a99b39-c561-a426-e053-dadaa90af4c2Guard Hand Sanitizing Gel
77668-003-322022-01-28C16284748780-1d6a99b39-c561-a426-e053-dadaa90af4c2Guard Hand Sanitizing Gel
77668-003-552022-01-28C16284748780-1d6a99b39-c561-a426-e053-dadaa90af4c2Guard Hand Sanitizing Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77668-003-04Guard Hand Sanitizing Gel0.118 L in 1 BOTTLEGEL0.1184
77668-003-05Guard Hand Sanitizing Gel18.9 L in 1 PAILGEL18.94
77668-003-08Guard Hand Sanitizing Gel0.236 L in 1 BOTTLEGEL0.2364
77668-003-10Guard Hand Sanitizing Gel3.785 L in 1 BOTTLEGEL3.7854
77668-003-16Guard Hand Sanitizing Gel0.473 L in 1 BOTTLEGEL0.4734
77668-003-27Guard Hand Sanitizing Gel1041 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL10414
77668-003-32Guard Hand Sanitizing Gel0.946 L in 1 BOTTLEGEL0.9464
77668-003-55Guard Hand Sanitizing Gel208.2 L in 1 DRUMGEL208.24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77668-003GUARD HAND SANITIZING GEL (ALCOHOL) GEL [GUARD PRODUCTS INC]4Legacy NDC, 8 package rows20200716_aa8790ae-e827-2771-e053-2a95a90a018b.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77668-00377668-003-10, 77668-003-04, 77668-003-08, 77668-003-05, 77668-003-16, 77668-003-32, 77668-003-55, 77668-003-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
PEG-40 HYDROGENATED LANOLIN959P5CXE48IACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALOE VERA FLOWER575DY8C1ERIACT
AMINOMETHYL PROPANEDIOLCZ7BU4QZJZIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
aa8790ae-e828-2771-e053-2a95a90a018baa8790ae-e827-2771-e053-2a95a90a018b2020-07-15WarningsExact identifier
spl id: aa8790ae-e828-2771-e053-2a95a90a018b
spl set id: aa8790ae-e827-2771-e053-2a95a90a018b

Reported adverse events (FAERS/openFDA)#

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