FDA.reportPublic FDA data

Guard

Manufacturer
Apollo Health and Beauty Care Inc
Effective date
2020-11-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:21

Label at a glance#

ProductGuard
Active ingredientALCOHOL
Label structure15 sections

Indications and uses

For Personal hand hygiene to help the spread of bacteria and can be used in place of hand washing if soap and water are not available.

Dosage and administration

For occasional and personal use Rub thoroughly into hands 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 0 F (43 0 C) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol (70%)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For Personal hand hygiene to help the spread of bacteria and can be used in place of hand washing if 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 Inhale.

Do not use

OTC - DO NOT USE SECTION

  • on children less than 2 months of age
  • on open skin wounds
  • on broken or damaged skin

Stop use and ask a doctor

OTC - STOP USE SECTION

If 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 Centre immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • For occasional and personal use
  • Rub thoroughly into hands 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 1100F (430C)
  • May discolor certain fabrics or surfaces

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), PEG-6, Fragrance (Parfum), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanate Crosspolymer

Questions or comments ?

OTC - QUESTIONS SECTION

1-866-695-3030

Principal Display Panel 2 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel 2 ozPrincipal Display Panel 2 oz

Principal Display Panel 8 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel 8 ozPrincipal Display Panel 8 oz

Principal Display Panel 15 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel 15 ozPrincipal Display Panel 15 oz

Principal Display Panel 32 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel 32 ozPrincipal Display Panel 32 oz

Principal Display Panel 40 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel 40 ozPrincipal Display Panel 40 oz

Principal Display Panel 64 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel 64 ozPrincipal Display Panel 64 oz

Principal Display Panel 128 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel 128 ozPrincipal Display Panel 128 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63148-622-102024-01-30C16284748780-11030e365-2eb8-111a-e063-dadaa90a10e2Drug Facts
63148-622-202024-01-30C16284748780-11030e365-2eb8-111a-e063-dadaa90a10e2Drug Facts
63148-622-302024-01-30C16284748780-11030e365-2eb8-111a-e063-dadaa90a10e2Drug Facts
63148-622-402024-01-30C16284748780-11030e365-2eb8-111a-e063-dadaa90a10e2Drug Facts
63148-622-502024-01-30C16284748780-11030e365-2eb8-111a-e063-dadaa90a10e2Drug Facts
63148-622-602024-01-30C16284748780-11030e365-2eb8-111a-e063-dadaa90a10e2Drug Facts
63148-622-702024-01-30C16284748780-11030e365-2eb8-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-622-10Guard59 mL in 1 BOTTLE, PLASTICGEL591
63148-622-20Guard236 mL in 1 BOTTLE, PLASTICGEL2361
63148-622-30Guard444 mL in 1 BOTTLE, PLASTICGEL4441
63148-622-40Guard946 mL in 1 BOTTLE, PLASTICGEL9461
63148-622-50Guard1182 mL in 1 BOTTLE, PLASTICGEL11821
63148-622-60Guard1892 mL in 1 BOTTLE, PLASTICGEL18921
63148-622-70Guard3785 mL in 1 BOTTLE, PLASTICGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-622GUARD (ETHYL ALCOHOL) GEL [APOLLO HEALTH AND BEAUTY CARE INC]1Legacy NDC, 7 package rows20201128_d27b0566-a60b-4835-aad9-d7dad7a29fde.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
63148-62263148-622-10, 63148-622-20, 63148-622-30, 63148-622-40, 63148-622-50, 63148-622-60, 63148-622-70

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
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%)2N8MDB79NAIACT

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
12e14df4-4076-4083-83f7-98d88585ab06d27b0566-a60b-4835-aad9-d7dad7a29fde2020-11-27WarningsExact identifier
spl id: 12e14df4-4076-4083-83f7-98d88585ab06
spl set id: d27b0566-a60b-4835-aad9-d7dad7a29fde

Reported adverse events (FAERS/openFDA)#

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