FDA.reportPublic FDA data

Warrior Hand Sanitizer Gel

Manufacturer
Prime Enterprises
Effective date
2022-05-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:42

Label at a glance#

ProductUnited Spirit of America Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Flammable: Do not use near hear, flame or while smoking.

OTC - WHEN USING SECTION

When using this product: Keep put of eyes. If product gets into eyes, rinse with water to remove. Avoid contact with broken skin. Do not inhale or ingest.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash or irritation develops and lasts.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow to dry without wiping.
  • For children under 6, use only under adult supervision.

Other Information

SPL UNCLASSIFIED SECTION

  • Do not store above 104 °F.
  • May discolor some fabrics, wood finishes and plastics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Carbomer, Glycerin, Isopropyl Myristate, Tocopherol, Water

Warrior Hand Sanitizer Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0553-92024-01-30C16284748780-11030e365-4bf4-111a-e063-dadaa90a10e2Warrior Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0553-9United Spirit of AmericaHand Sanitizer3700 mL in 1 BOTTLE, PLASTICGEL37001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0553UNITED SPIRIT OF AMERICA HAND SANITIZER (ETHYL ALCOHOL) GEL [PRIME ENTERPRISES]1Legacy NDC, 1 package rows20220526_dfc62a02-eaf6-608f-e053-2a95a90ac703.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-055358443-0553-9

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
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
dfc62b43-853f-5f15-e053-2a95a90a2de2dfc62a02-eaf6-608f-e053-2a95a90ac7032022-05-24WarningsExact identifier
spl id: dfc62b43-853f-5f15-e053-2a95a90a2de2
spl set id: dfc62a02-eaf6-608f-e053-2a95a90ac703

Reported adverse events (FAERS/openFDA)#

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