FDA.reportPublic FDA data

United Spirit of America

Manufacturer
Prime Enterprises
Effective date
2022-05-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:00:36

Label at a glance#

ProductUnited Spirit of America Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

Wet hands thoroughly with product and allow drying without wiping. Use only under adult supervision for children under 6 Not recommended for infants

Storage and handling

Do not store above 104 F. May discolor some fabrics Harmful to wood finishes and plastics

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.

SPL UNCLASSIFIED SECTION

Flammable: Do not while smoking or near heat of flame

OTC - WHEN USING SECTION

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

OTC - STOP USE 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 drying without wiping.
  • Use only under adult supervision for children under 6
  • Not recommended for infants

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Warrior Waterless Anti-Bacterial Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

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
58443-052358443-0523-3

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
TOCOPHEROLR0ZB2556P8IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CARBOMER 934Z135WT9208IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
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
dfc6742d-a5ad-58e2-e053-2a95a90a7ff6d5dcf543-2055-c389-e053-2a95a90af16a2022-05-24WarningsExact identifier
spl id: dfc6742d-a5ad-58e2-e053-2a95a90a7ff6
spl set id: d5dcf543-2055-c389-e053-2a95a90af16a

Reported adverse events (FAERS/openFDA)#

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