FDA.reportPublic FDA data

Guardian Gel

Manufacturer
Guardian Marine, LLC
Effective date
2020-09-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:08

Label at a glance#

ProductGuardian 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use (s)

INDICATIONS & USAGE SECTION

Hand rub to help reduce bacteria that potentially can cause disease.

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

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

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylic Polymer, Glycerin, Aloe Vera, Triethanolamine,Vitamin E, Aqua

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-505-7178

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC Numbers 79209-001-02, 79209-001-03, 79209-001-04, 79209-001-05, 79209-001-06 and 79209-001-07

70% Alcohol Gel with Aloe and Vitamin E.

GUARDIAN GEL

HAND SANITIZER

Unscented

2.25 mL (.07 oz)

250 mL (8.4 oz)

500 mL (16.9 oz)

1L (33 oz)

50 Gallon Barrel

1000L Tote

Vegan, Cruelty free, Paraben Free, Sulfate free, Caffeine free, Phthalate free, Triclosan-free.

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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
79209-001-022022-01-28C16284748780-1d6a99b39-9645-a426-e053-dadaa90af4c2ce65d083-05f2-4c5f-8672-84dfebd8b844
79209-001-032022-01-28C16284748780-1d6a99b39-9645-a426-e053-dadaa90af4c2ce65d083-05f2-4c5f-8672-84dfebd8b844
79209-001-042022-01-28C16284748780-1d6a99b39-9645-a426-e053-dadaa90af4c2ce65d083-05f2-4c5f-8672-84dfebd8b844
79209-001-052022-01-28C16284748780-1d6a99b39-9645-a426-e053-dadaa90af4c2ce65d083-05f2-4c5f-8672-84dfebd8b844
79209-001-062022-01-28C16284748780-1d6a99b39-9645-a426-e053-dadaa90af4c2ce65d083-05f2-4c5f-8672-84dfebd8b844
79209-001-072022-01-28C16284748780-1d6a99b39-9645-a426-e053-dadaa90af4c2ce65d083-05f2-4c5f-8672-84dfebd8b844

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79209-001-02Guardian Gel0.00225 L in 1 PACKAGEGEL0.002251
79209-001-03Guardian Gel0.25 L in 1 BOTTLEGEL0.251
79209-001-04Guardian Gel0.5 L in 1 BOTTLEGEL0.51
79209-001-05Guardian Gel1 L in 1 BOTTLEGEL11
79209-001-06Guardian Gel189.2711 L in 1 BOTTLEGEL189.27111
79209-001-07Guardian Gel1000 L in 1 BOTTLEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79209-001GUARDIAN GEL (ALCOHOL) GEL [GUARDIAN MARINE, LLC]1Legacy NDC, 6 package rows20200924_ce65d083-05f2-4c5f-8672-84dfebd8b844.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79209-00179209-001-02, 79209-001-03, 79209-001-04, 79209-001-05, 79209-001-06, 79209-001-07

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
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
WATER059QF0KO0RIACT

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
64a39f20-69cd-4175-affb-41c84c319352ce65d083-05f2-4c5f-8672-84dfebd8b8442020-09-22WarningsExact identifier
spl id: 64a39f20-69cd-4175-affb-41c84c319352
spl set id: ce65d083-05f2-4c5f-8672-84dfebd8b844

Reported adverse events (FAERS/openFDA)#

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