FDA.reportPublic FDA data

PRIME

Manufacturer
Prime Enterprises
Effective date
2022-04-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:04:21

Label at a glance#

ProductPRIME Advanced Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Put enough product in your palm to cover hands and rub hands together brisky until dry.

Storage and handling

Store below 104F(40C)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

For external use only. Flammable. do not use near heat, flame or while smoking.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In cases of contact. rinse eyes thoroughly with water. avoid contact with broken skin. do not inhale or ingest

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Put enough product in your palm to cover hands and rub hands together brisky until dry.

Other information

STORAGE AND HANDLING SECTION

  • Store below 104F(40C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PRIME ANTIBACTERIAL 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
58443-035758443-0357-4

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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
TOCOPHEROLR0ZB2556P8IACT
GLYCERINPDC6A3C0OXIACT

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
dbe9edaa-1a3c-6d36-e053-2a95a90ae9adae54cc23-47d0-4c40-e053-2a95a90a49322022-04-05WarningsExact identifier
spl id: dbe9edaa-1a3c-6d36-e053-2a95a90ae9ad
spl set id: ae54cc23-47d0-4c40-e053-2a95a90a4932

Reported adverse events (FAERS/openFDA)#

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