FDA.reportPublic FDA data

Guard Hand Sanitizer

Manufacturer
Apollo Health and Beauty Care Inc.
Effective date
2020-04-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:07:03

Label at a glance#

ProductGuard Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

to help reduce bacteria on the skin . For use when soap and water are not available.

Dosage and administration

put enough product in your palm to cover hands and rub hands together for at least 30 seconds. Allow to dry. children under 6 years should be supervised when using this product.

Storage and handling

store at a temperature below 110°F (43°C) may discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

to help reduce bacteria on the skin . For use when soap and water are not available.

Warnings 

WARNINGS SECTION

For external use only

  • flammable
  • keep away from source of heat or fire

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Do not use

OTC - DO NOT USE SECTION

  • on children less than 2 months of age
  • on open skin wounds
Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or redness develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • put enough product in your palm to cover hands and rub hands together for at least 30 seconds. Allow to dry.
  • children under 6 years should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

  • store at a temperature below 110°F (43°C)
  • may discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).

Questions or comments?

OTC - QUESTIONS SECTION

1-866-695-3030

Label copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of the labelimage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN1
902574ethanol 0.65 ML/ML Topical GelSCD1
902574ethyl alcohol 65 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63148-515-022024-01-30C16284748780-11030e365-42e7-111a-e063-dadaa90a10e2Drug Facts
63148-515-082024-01-30C16284748780-11030e365-42e7-111a-e063-dadaa90a10e2Drug Facts
63148-515-322024-01-30C16284748780-11030e365-42e7-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-515-02Guard Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL591
63148-515-08Guard Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2361
63148-515-32Guard Hand Sanitizer946 mL in 1 BOTTLE, PLASTICGEL9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-515GUARD HAND SANITIZER (ETHYL ALCOHOL) GEL [APOLLO HEALTH AND BEAUTY CARE INC.]1Legacy NDC, 3 package rows20200421_8b41e26c-c19c-4577-a50c-3cd678fe29e4.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63148-51563148-515-02, 63148-515-08, 63148-515-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
CARBOMER 934Z135WT9208IACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
e0e4d695-4d30-4dfe-b682-41a76d5cda2a8b41e26c-c19c-4577-a50c-3cd678fe29e42020-04-20WarningsExact identifier
spl id: e0e4d695-4d30-4dfe-b682-41a76d5cda2a
spl set id: 8b41e26c-c19c-4577-a50c-3cd678fe29e4

Reported adverse events (FAERS/openFDA)#

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