FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Neonatural SA de CV
Effective date
2020-07-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:22:31

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 below 100ºF (43ºC)

Label contents#

Full prescribing information#

Active Ingredient(s)

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 below 100ºF (43ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, carbomer, triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

125 mL NDC: 78103-001-01

PDP 125mlPDP 125ml

250 mL NDC: 78103-001-02

PDP 250mlPDP 250ml

500 mL NDC: 78103-001-03

PDP 500mlPDP 500ml

1000 mL NDC: 78103-001-04

PDP 1000mlPDP 1000ml

5000 mL NDC: 78103-001-05

PDP 5000mlPDP 5000ml

20000 mL NDC: 78103-001-06

PDP 20000mlPDP 20000ml

3785 mL NDC: 78103-001-07 GañonGañon

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78103-001-012023-01-30C16284748780-1f386c64a-43ee-0266-e053-dadaa90a7c1aa6bd316f-4262-2d95-e053-2a95a90ae0aa
78103-001-022023-01-30C16284748780-1f386c64a-43ee-0266-e053-dadaa90a7c1aa6bd316f-4262-2d95-e053-2a95a90ae0aa
78103-001-032023-01-30C16284748780-1f386c64a-43ee-0266-e053-dadaa90a7c1aa6bd316f-4262-2d95-e053-2a95a90ae0aa
78103-001-042023-01-30C16284748780-1f386c64a-43ee-0266-e053-dadaa90a7c1aa6bd316f-4262-2d95-e053-2a95a90ae0aa
78103-001-052023-01-30C16284748780-1f386c64a-43ee-0266-e053-dadaa90a7c1aa6bd316f-4262-2d95-e053-2a95a90ae0aa
78103-001-062023-01-30C16284748780-1f386c64a-43ee-0266-e053-dadaa90a7c1aa6bd316f-4262-2d95-e053-2a95a90ae0aa
78103-001-072023-01-30C16284748780-1f386c64a-43ee-0266-e053-dadaa90a7c1aa6bd316f-4262-2d95-e053-2a95a90ae0aa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78103-001-01Hand Sanitizer125 mL in 1 BOTTLEGEL1252
78103-001-02Hand Sanitizer250 mL in 1 BOTTLEGEL2502
78103-001-03Hand Sanitizer500 mL in 1 BOTTLEGEL5002
78103-001-04Hand Sanitizer1000 mL in 1 BOTTLEGEL10002
78103-001-05Hand Sanitizer5000 mL in 1 BOTTLEGEL50002
78103-001-06Hand Sanitizer20000 mL in 1 CONTAINERGEL200002
78103-001-07Hand Sanitizer3785 mL in 1 BOTTLEGEL37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78103-001HAND SANITIZER (ALCOHOL) GEL [NEONATURAL SA DE CV]2Legacy NDC, 7 package rows20200725_a6bd316f-4262-2d95-e053-2a95a90ae0aa.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
78103-00178103-001-01, 78103-001-02, 78103-001-03, 78103-001-04, 78103-001-05, 78103-001-06, 78103-001-07

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
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 9404Q93RCW27EIACT

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
ab2619ac-5152-7fff-e053-2995a90ad052a6bd316f-4262-2d95-e053-2a95a90ae0aa2020-07-23WarningsExact identifier
spl id: ab2619ac-5152-7fff-e053-2995a90ad052
spl set id: a6bd316f-4262-2d95-e053-2a95a90ae0aa

Reported adverse events (FAERS/openFDA)#

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