FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Precision Fluids
Effective date
2020-07-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:21:39

Label at a glance#

ProductHand 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 70.21% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, 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.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

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.

OTC - STOP USE SECTION

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

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.

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.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, sodium laureth sulfate, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 mL NDC: 78381-200-10

Jug LabelJug Label

18927 mL NDC: 78381-200-20

Pail LabelPail Label

208198 mL NDC: 78381-200-30

Drum LabelDrum Label

1040988 mL NDC: 78381-200-40

275 Label275 Label

1249185 mL NDC: 78381-200-50

330 Label330 Label

118927050 mL NDC: 78381-200-60

Bulk LabelBulk Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2372451ethanol 70.2 % Topical GelPSN3
2372451ethanol 0.702 ML/ML Topical GelSCD3
2372451ethanol 70.2 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78381-200-102022-01-28C16284748780-1d6a99b39-77d4-a426-e053-dadaa90af4c2a743c8d3-d53f-4ed5-e053-2995a90a181c
78381-200-202022-01-28C16284748780-1d6a99b39-77d4-a426-e053-dadaa90af4c2a743c8d3-d53f-4ed5-e053-2995a90a181c
78381-200-302022-01-28C16284748780-1d6a99b39-77d4-a426-e053-dadaa90af4c2a743c8d3-d53f-4ed5-e053-2995a90a181c
78381-200-402022-01-28C16284748780-1d6a99b39-77d4-a426-e053-dadaa90af4c2a743c8d3-d53f-4ed5-e053-2995a90a181c
78381-200-502022-01-28C16284748780-1d6a99b39-77d4-a426-e053-dadaa90af4c2a743c8d3-d53f-4ed5-e053-2995a90a181c
78381-200-602022-01-28C16284748780-1d6a99b39-77d4-a426-e053-dadaa90af4c2a743c8d3-d53f-4ed5-e053-2995a90a181c
78381-200-702022-01-28C16284748780-1d6a99b39-77d4-a426-e053-dadaa90af4c2a743c8d3-d53f-4ed5-e053-2995a90a181c
78381-200-802022-01-28C16284748780-1d6a99b39-77d4-a426-e053-dadaa90af4c2a743c8d3-d53f-4ed5-e053-2995a90a181c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78381-200-10Hand Sanitizer3785 mL in 1 JUGGEL37853
78381-200-20Hand Sanitizer18927 mL in 1 PAILGEL189273
78381-200-30Hand Sanitizer208198 mL in 1 DRUMGEL2081983
78381-200-40Hand Sanitizer1040988 mL in 1 TANKGEL10409883
78381-200-50Hand Sanitizer1249185 mL in 1 TANKGEL12491853
78381-200-60Hand Sanitizer18927050 mL in 1 TANKGEL189270503
78381-200-70Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL4733
78381-200-80Hand Sanitizer946 mL in 1 BOTTLE, PUMPGEL9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78381-200HAND SANITIZER (ALCOHOL) GEL [PRECISION FLUIDS]3Legacy NDC, 8 package rows20200717_a743c8d3-d53f-4ed5-e053-2995a90a181c.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
78381-20078381-200-10, 78381-200-20, 78381-200-30, 78381-200-40, 78381-200-50, 78381-200-60, 78381-200-70, 78381-200-80

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
SODIUM LAURETH SULFATEBPV390UAP0IACT

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
aa9abad6-2e0b-71fc-e053-2995a90aef72a743c8d3-d53f-4ed5-e053-2995a90a181c2020-07-16WarningsExact identifier
spl id: aa9abad6-2e0b-71fc-e053-2995a90aef72
spl set id: a743c8d3-d53f-4ed5-e053-2995a90a181c

Reported adverse events (FAERS/openFDA)#

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