FDA.reportPublic FDA data

State Line Distillery Hand Sanitizer

Manufacturer
State Line Distillery, LLC | State Line Distillery
Effective date
2020-04-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:36:31

Label at a glance#

ProductState Line Distillery Hand Sanitizer
Active ingredientALCOHOL
Label structure12 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 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

​Alcohol 80% v/v. Purpose: Antiseptic

Alcohol 80% v/vAlcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Antiseptic Hand SanitizerAntiseptic Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Use[s] Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.Use[s] 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 heat or flame

WarningsWarnings

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

Do Not UseDo Not Use

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

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

When Using This ProductWhen Using This Product

OTC - STOP USE SECTION

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

Stop UseStop Use

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.

Keep out of reach of childrenKeep out of reach of children

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.

DirectionsDirections

Other information

STORAGE AND HANDLING SECTION

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

Other InformationOther Information

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Inactive IngredientsInactive Ingredients

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 mL NDC: 75218-000-01

Principal Display PanelPrincipal Display Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75218-000-012022-01-21C16284748780-1c7ccaba7-16b0-fd44-e053-dadaa90aa01ba32113d2-4b08-18e0-e053-2995a90a80dc
75218-000-022022-01-21C16284748780-1c7ccaba7-16b0-fd44-e053-dadaa90aa01ba32113d2-4b08-18e0-e053-2995a90a80dc
75218-000-012021-07-23C16284748780-1c7ccaba7-16b0-fd44-e053-dadaa90aa01ba32113d2-4b08-18e0-e053-2995a90a80dc
75218-000-022021-07-23C16284748780-1c7ccaba7-16b0-fd44-e053-dadaa90aa01ba32113d2-4b08-18e0-e053-2995a90a80dc

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
75218-00075218-000-01, 75218-000-02

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
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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
d61ce5f1-fe94-7f09-e053-2995a90a714fa32113d2-4b08-18e0-e053-2995a90a80dc2022-01-21WarningsExact identifier
spl set id: a32113d2-4b08-18e0-e053-2995a90a80dc

Reported adverse events (FAERS/openFDA)#

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