FDA.reportPublic FDA data

FB HYDRATING HAND SANITIZER

Manufacturer
FAMILY DOLLAR SERVICES, LLC
Effective date
2025-10-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:41:10

Label at a glance#

ProductFB HYDRATING HAND SANITIZER
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Spray enough sanitizer in your palm to cover both hands. Rub hands together briskly until dry. Children under six should be supervised.

Storage and handling

① Protect the product in this container from excessive heat and direct sun. ② Store below 104° F (40°C). ③ May discolor certain fabrics.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Use hand sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

Flammable: Keep away from fire or flame.

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not using children less than 2 months of age on open skin wounds.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and see 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

Spray enough sanitizer in your palm to cover both hands. Rub hands together briskly until dry. Children under six should be supervised.

Other information

STORAGE AND HANDLING SECTION

① Protect the product in this container from excessive heat and direct sun.

② Store below 104° F (40°C).

③ May discolor certain fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-778-01FB HYDRATING HAND SANITIZER50 mL in 1 BOTTLEGEL503

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-77855319-778-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-03-19full-release2026-06-01 00:57:25

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
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b650bd-18fe-8696-e063-6394a90aa9a22025-10-30WarningsExact identifier
ndc (package): 55319-778-01
ndc (product): 55319-778
ndc11 (package): 55319077801
spl id: 426b0a14-8042-5182-e063-6394a90a216c
spl set id: 20b650bd-18fe-8696-e063-6394a90aa9a2

Reported adverse events (FAERS/openFDA)#

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