FDA.reportPublic FDA data

HANDS FIRST TM

Manufacturer
Hands First, LLC.
Effective date
2021-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:19

Label at a glance#

ProductHANDS FIRST TM
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

SPL UNCLASSIFIED SECTION

  • For handwashing to decrease bacteria on the skin
  • For temporary protection of minor cuts, scrapes, burns and chapped or cracked skin

Warning

WARNINGS SECTION

  • For external use only.
  • Keep out of the reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.
  • Do not use in the eyes.
  • Do not use on deep or puncture wounds, animal bites or serious burns.
  • Extended use may increase risk of sunburn.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • symptoms worsen, last for more than seven days, or new symptoms occur at any time

Direction

SPL UNCLASSIFIED SECTION

  • Uses as needed.
  • Remove cap and pump foam into palm of hands.
  • Rub foam onto hands.
  • Allow to air dry.

Other information

SPL UNCLASSIFIED SECTION

  • save carton for full directions and warnings
  • store between 20 to 25oC (68 to 77oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cocamidopropyl betaine , allantoin, glycolic acid, dimethicone, aloe vera leaf, lavender extract, colloidal silver, tetrasodium EDTA, phenoxyethanol, ethylhexyl glycerine.

Questions?

OTC - QUESTIONS SECTION

Call 1-800-603-0589 between 9am and 5pm (EST) Monday through Friday or visit www.handsfirst.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hands First

4 in 1 action

Alcohol Free Foam

Hand Sanitizer

Doctor created and hospital tested

Sanitize anytime, anywhere

Temporarily protect minor cuts and scrapes

Hydrate your skin

Clean without water

Kills 99.99% of germs

6 fl oz (177mL)

foam
foam

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN1
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD1
1020365benzalkonium chloride 0.13 % Topical FoamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81858-021-012023-01-30C16284748780-1f386c649-ee3f-0266-e053-dadaa90a7c1aDrug Facts
81858-021-022023-01-30C16284748780-1f386c649-ee3f-0266-e053-dadaa90a7c1aDrug Facts
81858-021-042023-01-30C16284748780-1f386c649-ee3f-0266-e053-dadaa90a7c1aDrug Facts
81858-021-062023-01-30C16284748780-1f386c649-ee3f-0266-e053-dadaa90a7c1aDrug Facts
81858-021-082023-01-30C16284748780-1f386c649-ee3f-0266-e053-dadaa90a7c1aDrug Facts
81858-021-122023-01-30C16284748780-1f386c649-ee3f-0266-e053-dadaa90a7c1aDrug Facts
81858-021-162023-01-30C16284748780-1f386c649-ee3f-0266-e053-dadaa90a7c1aDrug Facts
81858-021-322023-01-30C16284748780-1f386c649-ee3f-0266-e053-dadaa90a7c1aDrug Facts
81858-021-642023-01-30C16284748780-1f386c649-ee3f-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81858-021-01HANDS FIRST TM3785 mL in 1 BOTTLESOLUTION37851
81858-021-02HANDS FIRST TM59 mL in 1 BOTTLESOLUTION591
81858-021-04HANDS FIRST TM118 mL in 1 BOTTLESOLUTION1181
81858-021-06HANDS FIRST TM177 mL in 1 BOTTLESOLUTION1771
81858-021-08HANDS FIRST TM236 mL in 1 BOTTLESOLUTION2361
81858-021-12HANDS FIRST TM354 mL in 1 BOTTLESOLUTION3541
81858-021-16HANDS FIRST TM473 mL in 1 BOTTLESOLUTION4731
81858-021-32HANDS FIRST TM946 mL in 1 BOTTLESOLUTION9461
81858-021-64HANDS FIRST TM1892 mL in 1 BOTTLESOLUTION18921

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81858-021HANDS FIRST TM (BENZALKONIUM CHLORIDE) SOLUTION [HANDS FIRST, LLC.]1Legacy NDC, 9 package rows20210513_d64e5183-07b2-4254-967f-289b52a9ff8e.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81858-02181858-021-02, 81858-021-04, 81858-021-06, 81858-021-08, 81858-021-12, 81858-021-16, 81858-021-32, 81858-021-64, 81858-021-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ALLANTOIN344S277G0ZIACT
GLYCOLIC ACID0WT12SX38SIACT
DIMETHICONE92RU3N3Y1OIACT
ALOE VERA LEAFZY81Z83H0XIACT
SILVER3M4G523W1GIACT
ENGLISH LAVENDER OILZBP1YXW0H8IACT
EDETATE SODIUMMP1J8420LUIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
b9a6a16f-4f94-434f-9ec8-999ac95781f5d64e5183-07b2-4254-967f-289b52a9ff8e2021-05-07WarningsExact identifier
spl id: b9a6a16f-4f94-434f-9ec8-999ac95781f5
spl set id: d64e5183-07b2-4254-967f-289b52a9ff8e

Reported adverse events (FAERS/openFDA)#

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