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 22:04:26

Label at a glance#

ProductPrime Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand sanitizer to help reduce bacteria on the skin.

Dosage and administration

Directions: Put enough product in your palm to cover hands and rub hands together briskly until dry.

Storage and handling

Other information Store below 104ºF (40ºC).

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

Flammable

SPL UNCLASSIFIED SECTION

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 case of contact, rinse eyes throughly 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

Directions: Put enough product in your palm to cover hands and rub hands together briskly until dry.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

Other information

Store below 104ºF (40ºC).

OTC - QUESTIONS SECTION

Questions and comments Prime Enterprises 16363 NW 49th Avenue,Miami,Fl 33014

Prime Antibacterial Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple 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
58443-048958443-0489-9

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
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
dbe9e7e4-67cd-2dc8-e053-2995a90a12e5d2bbd150-c1b2-9427-e053-2a95a90abb832022-04-05WarningsExact identifier
spl id: dbe9e7e4-67cd-2dc8-e053-2995a90a12e5
spl set id: d2bbd150-c1b2-9427-e053-2a95a90abb83

Reported adverse events (FAERS/openFDA)#

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