FDA.reportPublic FDA data

Florida Laboratories - Hand Sanitizer

Manufacturer
Florida Laboratories, Inc.
Effective date
2023-10-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:24:37

Label at a glance#

ProductFlorida Laboratories - Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 80 % v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable, keep away from heat or flame.

Do not use

■ in children less than 2 months of age.

■ on open skin wounds.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222).

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

glycerin, hydrogen peroxide, purified water USP

SPL UNCLASSIFIED SECTION

Alcohol Antiseptic 80%

Topical Solution

Non-sterile Solution

DISTRIBUTED BY:

Florida Laboratories Inc, Fort Lauderdale, FL 33309

www.flalab.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78213-100-012023-10-10C16284748780-10191ceaa-6443-198a-e063-dbdaa90aec3eFlorida Laboratories Hand Sanitizer Antibacterial
78213-100-022023-10-10C16284748780-10191ceaa-6443-198a-e063-dbdaa90aec3eFlorida Laboratories Hand Sanitizer Antibacterial
78213-100-032023-10-10C16284748780-10191ceaa-6443-198a-e063-dbdaa90aec3eFlorida Laboratories Hand Sanitizer Antibacterial
78213-100-012023-07-28C16284748780-10191ceaa-6443-198a-e063-dbdaa90aec3eFlorida Laboratories Hand Sanitizer Antibacterial
78213-100-022023-07-28C16284748780-10191ceaa-6443-198a-e063-dbdaa90aec3eFlorida Laboratories Hand Sanitizer Antibacterial
78213-100-032023-07-28C16284748780-10191ceaa-6443-198a-e063-dbdaa90aec3eFlorida Laboratories Hand Sanitizer Antibacterial

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78213-10078213-100-03, 78213-100-01, 78213-100-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
3164d44e-935f-429d-9f62-0b8fe986e66f5b97bd70-267c-4dba-86d0-578cf1f18ac62023-10-10WarningsExact identifier
spl id: 3164d44e-935f-429d-9f62-0b8fe986e66f
spl set id: 5b97bd70-267c-4dba-86d0-578cf1f18ac6

Reported adverse events (FAERS/openFDA)#

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