FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
HPPE, LLC
Effective date
2020-06-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:08

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

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% 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

hydroxyethylcellulose, isopropyl myristate, propylene glycol, water

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

237 mL NDC: 58039-119-03

237 mL Label237 mL Label355 mL NDC: 58039-119-04

355 mL Label355 mL Label473 mL NDC: 58039-119-05

473 mL Label473 mL Label

3.8 L NDC: 58039-119-06

Front Label 3.8 LFront Label 3.8 L

Back Label 3.8 LBack Label 3.8 L

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58039-119-032022-01-28C16284748780-1d6a99b39-f536-a426-e053-dadaa90af4c2a84a4879-321a-7d2d-e053-2995a90abca7
58039-119-042022-01-28C16284748780-1d6a99b39-f536-a426-e053-dadaa90af4c2a84a4879-321a-7d2d-e053-2995a90abca7
58039-119-052022-01-28C16284748780-1d6a99b39-f536-a426-e053-dadaa90af4c2a84a4879-321a-7d2d-e053-2995a90abca7
58039-119-062022-01-28C16284748780-1d6a99b39-f536-a426-e053-dadaa90af4c2a84a4879-321a-7d2d-e053-2995a90abca7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58039-119-03Hand Sanitizer237 mL in 1 BOTTLEGEL2371
58039-119-04Hand Sanitizer355 mL in 1 BOTTLEGEL3551
58039-119-05Hand Sanitizer473 mL in 1 BOTTLEGEL4731
58039-119-06Hand Sanitizer3800 mL in 1 JUGGEL38001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58039-119HAND SANITIZER (ALCOHOL) GEL [HPPE, LLC]1Legacy NDC, 4 package rows20200618_a84a4879-321a-7d2d-e053-2995a90abca7.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
58039-11958039-119-03, 58039-119-04, 58039-119-05, 58039-119-06

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
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALCOHOL3K9958V90MACTIB
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT

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
a84a4879-321b-7d2d-e053-2995a90abca7a84a4879-321a-7d2d-e053-2995a90abca72020-06-17WarningsExact identifier
spl id: a84a4879-321b-7d2d-e053-2995a90abca7
spl set id: a84a4879-321a-7d2d-e053-2995a90abca7

Reported adverse events (FAERS/openFDA)#

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