FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Bullet Line, LLC
Effective date
2021-12-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:45:44

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol (64%)

OTC - PURPOSE SECTION

Antimicrobial

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

Purified Water, Carbopol, glycerin, glycereth-2-cocoate, triethanolamine

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

Gel Sanitizer Back LabelGel Sanitizer Back Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
247835ethanol 62 % Topical SolutionPSN4
247835ethanol 0.62 ML/ML Topical SolutionSCD4
247835ethanol 62 % Topical SolutionSY4
247835ethyl alcohol 62 % Topical SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
19392-210-062023-01-30C16284748780-1f386c649-a28e-0266-e053-dadaa90a7c1aDrug Facts
19392-210-072023-01-30C16284748780-1f386c649-a28e-0266-e053-dadaa90a7c1aDrug Facts
19392-210-082023-01-30C16284748780-1f386c649-a28e-0266-e053-dadaa90a7c1aDrug Facts
19392-210-092023-01-30C16284748780-1f386c649-a28e-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
19392-210-06Hand Sanitizer15 mL in 1 BOTTLE, PLASTICLIQUID154
19392-210-07Hand Sanitizer30 mL in 1 BOTTLE, PLASTICLIQUID304
19392-210-08Hand Sanitizer44 mL in 1 BOTTLE, PLASTICLIQUID444
19392-210-09Hand Sanitizer60 mL in 1 BOTTLE, PLASTICLIQUID604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
19392-210HAND SANITIZER (ALCOHOL) LIQUID [BULLET LINE, LLC]4Legacy NDC, 4 package rows20211218_a61de07b-06c8-8edf-e053-2995a90af1c8.zip

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
19392-21019392-210-07, 19392-210-06, 19392-210-08, 19392-210-09

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
EDETOLQ4R969U9FRIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
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
d35a6841-3d38-b273-e053-2a95a90ad352a61de07b-06c8-8edf-e053-2995a90af1c82021-12-17WarningsExact identifier
spl id: d35a6841-3d38-b273-e053-2a95a90ad352
spl set id: a61de07b-06c8-8edf-e053-2995a90af1c8

Reported adverse events (FAERS/openFDA)#

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