FDA.reportPublic FDA data

One Eight Distilling Hand Sanitizer

Manufacturer
One-Eight Distilling, LLC
Effective date
2020-03-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:38:19

Label at a glance#

ProductOne Eight Distilling Hand Sanitizer
Active ingredientALCOHOL
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient(s)

Alcohol 80% v/v ... Antiseptic

backback

OTC - PURPOSE SECTION

Use[s]

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

OTC - DO NOT USE SECTION

Do not use

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

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.

OTC - STOP USE SECTION

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

OTC - WHEN USING SECTION

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

OTHER SAFETY INFORMATION

Other information

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

WARNINGS AND PRECAUTIONS SECTION

Warnings

For external use only. Flammable. Keep away from heat or flame.

INSTRUCTIONS FOR USE 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.

INACTIVE INGREDIENT SECTION

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

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.

WARNINGS SECTION

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

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

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.

INDICATIONS & USAGE SECTION

Use[s]

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

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[DISTRICT MADE logo]

[WE ARE WASHINGTON DC logo]

[ONE EIGHT DISTILLING logo]

ONE EIGHT DISTILLING, LLC

BATCH ______ DATE: _______

ALCOHOL ANTISPECTIC 80%

TOPICAL SOLUTION

HAND SANITIZER

NON-STERILE SOLUTION frontfront

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
74211-000174211-0001-1, 74211-0001-2, 74211-0001-3

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
WATER059QF0KO0RIACT
GLYCEROL FORMAL3L7GR2604EIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
ALCOHOL3K9958V90MACTIB

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
d658d468-8a71-0b62-e053-2995a90a466ca213ed66-8bef-70bc-e053-2995a90abc192022-01-24WarningsExact identifier
spl set id: a213ed66-8bef-70bc-e053-2995a90abc19

Reported adverse events (FAERS/openFDA)#

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