Hand Sanitizer

Manufacturer
Unitrex Ltd.
Effective date
2023-01-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:41:45

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

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 15-30°C (59-86°F) Avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

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 fire or flame.

Do not use

OTC - DO NOT USE SECTION

Do not use

  • In children less than 2 months of age
  • On open skin wounds

When using this product

OTC - WHEN USING SECTION

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

Stop use

OTC - STOP USE SECTION

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

Keep out of reach of children

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

  • 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf extract, glycerin, sterile distilled water, lemon fragrance

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)

SPL UNCLASSIFIED SECTION

sparoom

ON THE GO

HAND SANITIZER

Kills 99.99% of Common Germs

Made with Aloe and Essential Oil

3 - 0.50 fl oz (15 mL) Sanitizers

Distributed by Unitrex Ltd. / SpaRoom
5060 Taylor Rd, Cleveland OH 44128

©2020 Unitrex

Questions? Toll-Free 1-833-729-4859
Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

back panelback panel

front labelfront label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78553-4339-32023-01-04C16284748780-1e4f33bdf-af2c-d8a0-e053-dadaa90a6e4esparoom On The Go Hand Sanitizer
78553-4339-32022-07-29C16284748780-1e4f33bdf-af2c-d8a0-e053-dadaa90a6e4esparoom On The Go Hand Sanitizer

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78553-433978553-4339-3

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
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT

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
f172451d-17bb-5db2-e053-2a95a90a5644ad1a4730-13a5-46e1-e053-2a95a90a23112023-01-04WarningsExact identifier
spl id: f172451d-17bb-5db2-e053-2a95a90a5644
spl set id: ad1a4730-13a5-46e1-e053-2a95a90a2311

Reported adverse events (FAERS/openFDA)#

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