FDA.reportPublic FDA data

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 21:41:46

Label at a glance#

ProductHand Sanitizer Lemon
Active ingredientALCOHOL, ISOPROPYL ALCOHOL
Label structure20 sections

Label contents#

Full prescribing information#

Hand Sanitizer

OTC - ACTIVE INGREDIENT SECTION

Active ingredientAlcohol 62%

Hand Sanitizer

OTC - PURPOSE SECTION

Purpose Antiseptic

Hand Sanitizer

INDICATIONS & USAGE SECTION

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

Hand Sanitizer

WARNINGS SECTION

Warnings

For exernal use only. Flammable. Keep away from fire or flame.

Hand Sanitizer

OTC - DO NOT USE SECTION

Do not use

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

Hand Sanitizer

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.

Hand Sanitizer

OTC - STOP USE SECTION

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

Hand Sanitizer

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Hand Sanitizer

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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.

Hand Sanitizer

INACTIVE INGREDIENT SECTION

Inactive ingredients Aloe, glycerin, sterile distilled water, lemon fragrance

Hand Sanitizer

SPL UNCLASSIFIED SECTION

Other information

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

Hand Sanitizer

SPL UNCLASSIFIED SECTION

sparoom ®

ON THE GO

HAND SANITIZER

Made with Aloe and Essential Oil

0.50 fl oz (15mL)

2021 UNITREX ® LTD.

5060 Taylor Road

Cleveland, Ohio 44128

Made in China

Alcohol wipes

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Isopropyl Alcohol 70%

Alcohol wipes

OTC - PURPOSE SECTION

Purpose Antiseptic

Alcohol wipes

INDICATIONS & USAGE SECTION

Use

Isopropyl alcohol antiseptic wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Alcohol wipes

WARNINGS SECTION

Warnings

For external use only. Flammable. Keep away from heat or flame. Not suitable for delicate skin.

Alcohol wipes

OTC - DO NOT USE SECTION

Do not use

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

Alcohol wipes

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.

Alcohol wipes

OTC - STOP USE SECTION

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

Alcohol wipes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of chilldren. If swallowed, get medical help or contact a Poison Control Center right away.

Alcohol wipes

DOSAGE & ADMINISTRATION SECTION

Directions

  • Wipe surface of hands with wipe.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Alcohol wipes

INACTIVE INGREDIENT SECTION

Inactive ingredients purified water USP, Lemon fragrance

Alcohol wipes

OTC - QUESTIONS SECTION

Questions? Toll free 833-729-4859

Alcohol wipes

SPL UNCLASSIFIED SECTION

Other information

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

Alcohol wipes

SPL UNCLASSIFIED SECTION

sparoom ®

Lemon Scent • Made with Essential Oil

SANITIZING

ALCOHOL WIPES

10 PCS

Isopropyl Alcohol 70%

Distributed by Unitrex Ltd. / SpaRoom

5060 Taylor Rd, Cleveland, OH 44128

©2021 Unitrex

Made in China

Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Alcohol wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

wipe labelwipe label

Kit label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

kit labelkit label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78553-4743-52023-01-04C16284748780-1e4f33bdf-9fdf-d8a0-e053-dadaa90a6e4eLemon Hand Sanitizer
78553-4743-52022-07-29C16284748780-1e4f33bdf-9fdf-d8a0-e053-dadaa90a6e4eLemon Hand Sanitizer

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78553-474378553-4743-5
78553-474178553-4741-4
78553-474278553-4742-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
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
f1723106-12ee-226c-e053-2a95a90af9a9b58434b4-d730-2f17-e053-2995a90a93612023-01-04WarningsExact identifier
spl id: f1723106-12ee-226c-e053-2a95a90af9a9
spl set id: b58434b4-d730-2f17-e053-2995a90a9361

Reported adverse events (FAERS/openFDA)#

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