FDA.reportPublic FDA data

ClearGuard Hand Sanitizer

Manufacturer
EVP International, LLC
Effective date
2021-02-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:11

Label at a glance#

ProductClearGuard Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Alcohol 80% v/v

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • hand sanitizer to help reduce bacteria that potentially can cause disease
  • for use when soap and water are not available

WARNINGS SECTION

Warnings

For external use only

Flammable, keep away from heat or flame.

OTC - DO NOT USE SECTION

Do not use

  • 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.

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 medial help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

Other information

  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ClearGuard™

HAND SANITIZER

Alcohol 80% Antiseptic Topical Solution

100 individual packets

0.07 fl oz (2ml) each

ClearGuard 100CT PDPClearGuard 100CT PDPClearGuard Bag BackClearGuard Bag Back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80996-001-102023-01-30C16284748780-1f386c64a-4043-0266-e053-dadaa90a7c1aClearGuard Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80996-001-10ClearGuard Hand Sanitizer2 mL in 1 PACKETSOLUTION21
80996-001-10ClearGuard Hand Sanitizer100 in 1 BAGSOLUTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80996-001CLEARGUARD HAND SANITIZER (ALCOHOL) SOLUTION [EVP INTERNATIONAL, LLC]1Legacy NDC, 2 package rows20210218_b6fd62ec-f86e-82e7-e053-2a95a90a802e.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80996-00180996-001-10

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
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VIACT

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
b6fd62ec-f86f-82e7-e053-2a95a90a802eb6fd62ec-f86e-82e7-e053-2a95a90a802e2021-02-17WarningsExact identifier
spl id: b6fd62ec-f86f-82e7-e053-2a95a90a802e
spl set id: b6fd62ec-f86e-82e7-e053-2a95a90a802e

Reported adverse events (FAERS/openFDA)#

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