FDA.reportPublic FDA data

Linstol Refreshing and Cleaning Hand Sanitizer

Manufacturer
Linstol USA, LLC
Effective date
2022-12-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:52:35

Label at a glance#

ProductLinstol Refreshing and Cleansing Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand sanitizer to help reduce bacteria on the skin

Dosage and administration

Wet hands thoroughly with product and rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

Flammable. Keep away from fire or flame.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use or ask a doctor if irritation or rash appears and lasts.

  • You may report side effects to FDA at 1-800-FDA-1088.

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 rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Carbomer, Fragrance, Glycerin, Racementhol, Trolamine.

SPL UNCLASSIFIED SECTION

Distributed by: Linstol USA, LLC
Naples, FL 34114

PRINCIPAL DISPLAY PANEL - 2 ml Packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REFRESHING & CLEANSING

HAND
SANITISER

Contains 75% Alcohol

2ml / 0.07 fl. oz.
PARABEN & TRICLOSAN FREE

PRINCIPAL DISPLAY PANEL - 2 ml Packet
PRINCIPAL DISPLAY PANEL - 2 ml Packet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN5
1305100ethanol 0.75 ML/ML Topical GelSCD5
1305100ethanol 75 % Topical GelSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76982-3864-02024-01-30C16284748780-11030e365-2c61-111a-e063-dadaa90a10e2Linstol Refreshing & Cleaning Hand Sanitizer
76982-3864-12024-01-30C16284748780-11030e365-2c61-111a-e063-dadaa90a10e2Linstol Refreshing & Cleaning Hand Sanitizer
76982-3864-22024-01-30C16284748780-11030e365-2c61-111a-e063-dadaa90a10e2Linstol Refreshing & Cleaning Hand Sanitizer
76982-3864-32024-01-30C16284748780-11030e365-2c61-111a-e063-dadaa90a10e2Linstol Refreshing & Cleaning Hand Sanitizer
76982-3864-42024-01-30C16284748780-11030e365-2c61-111a-e063-dadaa90a10e2Linstol Refreshing & Cleaning Hand Sanitizer
76982-3864-52024-01-30C16284748780-11030e365-2c61-111a-e063-dadaa90a10e2Linstol Refreshing & Cleaning Hand Sanitizer
76982-3864-62024-01-30C16284748780-11030e365-2c61-111a-e063-dadaa90a10e2Linstol Refreshing & Cleaning Hand Sanitizer
76982-3864-72024-01-30C16284748780-11030e365-2c61-111a-e063-dadaa90a10e2Linstol Refreshing & Cleaning Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76982-3864-0Linstol Refreshing and Cleansing Hand Sanitizer2 mL in 1 PACKETGEL25
76982-3864-1Linstol Refreshing and Cleansing Hand Sanitizer15 mL in 1 TUBEGEL155
76982-3864-2Linstol Refreshing and Cleansing Hand Sanitizer30 mL in 1 BOTTLE, PLASTICGEL305
76982-3864-3Linstol Refreshing and Cleansing Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL595
76982-3864-4Linstol Refreshing and Cleansing Hand Sanitizer118 mL in 1 BOTTLE, PLASTICGEL1185
76982-3864-5Linstol Refreshing and Cleansing Hand Sanitizer236 mL in 1 BOTTLE, PUMPGEL2365
76982-3864-6Linstol Refreshing and Cleansing Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5005
76982-3864-7Linstol Refreshing and Cleansing Hand Sanitizer532 mL in 1 BOTTLE, PUMPGEL5325

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76982-3864LINSTOL REFRESHING AND CLEANSING HAND SANITIZER (ALCOHOL) GEL [LINSTOL USA, LLC]5Legacy NDC, 8 package rows20221223_71dd1b18-c573-44c6-b544-3ad4d437a2ef.zip

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
76982-386476982-3864-0, 76982-3864-1, 76982-3864-2, 76982-3864-3, 76982-3864-4, 76982-3864-5, 76982-3864-6, 76982-3864-7

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
RACEMENTHOLYS08XHA860IACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
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
f0591141-fb32-00a4-e053-2a95a90aab8771dd1b18-c573-44c6-b544-3ad4d437a2ef2022-12-21WarningsExact identifier
spl id: f0591141-fb32-00a4-e053-2a95a90aab87
spl set id: 71dd1b18-c573-44c6-b544-3ad4d437a2ef

Reported adverse events (FAERS/openFDA)#

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