FDA.reportPublic FDA data

81422-008 Hand Sanitizer Gel

Manufacturer
Shenzhen Lynns Industrial Co., Ltd.
Effective date
2021-01-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:02

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

·wet hands thoroughly with product and allow to dry without wiping. ·For children under 6, use only under adult supervision.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

75%ethyl alcohol by volume....antimicrobial

Purpose

OTC - PURPOSE SECTION

antimicrobial

Use

INDICATIONS & USAGE SECTION

Use to help reduce bacterial on skin.

Warnings

WARNINGS SECTION

Flammable.External use only

Do not use on open skin wounds or children under 2 months of age

When using this product avoid contact with eyes.If case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

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

Do not use

OTC - DO NOT USE SECTION

Do not use on open skin wounds or children under 2 months of age

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.If case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

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

·wet hands thoroughly with product and allow to dry without wiping.
·For children under 6, use only under adult supervision.

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

aloe barbadensis leaf juice, carbomer, glycerin, purified water, triethanolamine, tocopheryl acetate.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

81422-008-25--Hand Sanitizer Gel 250ml

81422-008-25--Hand Sanitizer Gel 250ml81422-008-25--Hand Sanitizer Gel 250ml

81422-008-30--Hand Sanitizer Gel 30ml

81422-008-30--Hand Sanitizer Gel 30ml81422-008-30--Hand Sanitizer Gel 30ml

81422-008-37--Hand Sanitizer Gel 1 Gallon

81422-008-37--Hand Sanitizer Gel 1 Gallon81422-008-37--Hand Sanitizer Gel 1 Gallon

81422-008-50--Hand Sanitizer Gel 50ml

81422-008-50--Hand Sanitizer Gel 50ml81422-008-50--Hand Sanitizer Gel 50ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81422-008-252022-07-29C16284748780-1e4f33bdf-9d44-d8a0-e053-dadaa90a6e4e81422-008 Hand Sanitizer Gel
81422-008-302022-07-29C16284748780-1e4f33bdf-9d44-d8a0-e053-dadaa90a6e4e81422-008 Hand Sanitizer Gel
81422-008-372022-07-29C16284748780-1e4f33bdf-9d44-d8a0-e053-dadaa90a6e4e81422-008 Hand Sanitizer Gel
81422-008-502022-07-29C16284748780-1e4f33bdf-9d44-d8a0-e053-dadaa90a6e4e81422-008 Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81422-008-25Hand Sanitizer250 mL in 1 BOTTLEGEL2501
81422-008-30Hand Sanitizer30 mL in 1 BOTTLEGEL301
81422-008-37Hand Sanitizer3785 mL in 1 BOTTLEGEL37851
81422-008-50Hand Sanitizer50 mL in 1 BOTTLEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81422-008HAND SANITIZER (HAND SANITIZER GEL) GEL [SHENZHEN LYNNS INDUSTRIAL CO., LTD.]1Legacy NDC, 4 package rows20210119_b9280317-39a5-d5d7-e053-2a95a90a3b7a.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81422-00881422-008-25, 81422-008-30, 81422-008-37, 81422-008-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
b927e5bd-3c8a-444e-e053-2a95a90a34a1b9280317-39a5-d5d7-e053-2a95a90a3b7a2021-01-18WarningsExact identifier
spl id: b927e5bd-3c8a-444e-e053-2a95a90a34a1
spl set id: b9280317-39a5-d5d7-e053-2a95a90a3b7a

Reported adverse events (FAERS/openFDA)#

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