Hand Sanitizer

Manufacturer
Bullet Line, LLC
Effective date
2020-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:54

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol (80%)

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin

WARNINGS SECTION

Flammable - keep away from open flame.

For external use only.

Do not use in or near the eyes.

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

Keep out of reach of children.

If swallowed, contact a doctor or Poison Control Center right away.

INACTIVE INGREDIENT SECTION

Deionized Water, glycerin USP (glycerol), hydroxypropyl cellulose, hydrogen peroxide USP

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, contact a doctor or Poison Control center right away.

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Back LabelBack Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN1
1041498ethanol 0.8 ML/ML Topical GelSCD1
1041498ethanol 80 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
19392-220-012022-01-28C16284748780-1d6a99b39-f4cd-a426-e053-dadaa90af4c2Drug Facts
19392-220-022022-01-28C16284748780-1d6a99b39-f4cd-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
19392-220-01Hand Sanitizer15 mL in 1 BOTTLE, PLASTICGEL151
19392-220-02Hand Sanitizer30 mL in 1 BOTTLE, PLASTICGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
19392-220HAND SANITIZER (ALCOHOL) GEL [BULLET LINE, LLC]1Legacy NDC, 2 package rows20200610_a7a8e70a-0da7-5f90-e053-2995a90ace92.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
19392-22019392-220-02, 19392-220-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
a7a8e70a-0da6-5f90-e053-2995a90ace92a7a8e70a-0da7-5f90-e053-2995a90ace922020-06-09WarningsExact identifier
spl id: a7a8e70a-0da6-5f90-e053-2995a90ace92
spl set id: a7a8e70a-0da7-5f90-e053-2995a90ace92

Reported adverse events (FAERS/openFDA)#

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