FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Química Blantex, S.A. de C.V.
Effective date
2020-07-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:22:08

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(s)

OTC - ACTIVE INGREDIENT SECTION

Product: 78342-001 Alcohol 70% v/v. Purpose: Antiseptic

Product: 78342-002 Alcohol 80% 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

Product 78342-001: glycerin, carbomer, triethanolamine, purified water USP

Product 78342-002: glycerin, carbomer, triethanolamine, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL NDC: 78342-001-01 500 ml 70500 ml 70

1000 mL NDC: 78342-001-02 1000L 701000L 70

20000 mL NDC: 78342-001-03 20 l 8020 l 80

500 mL NDC: 78342-002-01 500 ml 80500 ml 80

1000 mL NDC: 78342-002-02 1000 ml 801000 ml 80

20000 mL NDC: 78342-002-03 20 litros 8020 litros 80

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
1041498ethanol 80 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
1041498ethanol 0.8 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
1041498ethanol 80 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78342-001-012022-01-28C16284748780-1d6a99b39-def5-a426-e053-dadaa90af4c2a6a57d68-c99d-977a-e053-2995a90a817f
78342-001-022022-01-28C16284748780-1d6a99b39-def5-a426-e053-dadaa90af4c2a6a57d68-c99d-977a-e053-2995a90a817f
78342-001-032022-01-28C16284748780-1d6a99b39-def5-a426-e053-dadaa90af4c2a6a57d68-c99d-977a-e053-2995a90a817f
78342-001-042022-01-28C16284748780-1d6a99b39-def5-a426-e053-dadaa90af4c2a6a57d68-c99d-977a-e053-2995a90a817f
78342-002-012022-01-28C16284748780-1d6a99b39-def5-a426-e053-dadaa90af4c2a6a57d68-c99d-977a-e053-2995a90a817f
78342-002-022022-01-28C16284748780-1d6a99b39-def5-a426-e053-dadaa90af4c2a6a57d68-c99d-977a-e053-2995a90a817f
78342-002-032022-01-28C16284748780-1d6a99b39-def5-a426-e053-dadaa90af4c2a6a57d68-c99d-977a-e053-2995a90a817f
78342-002-042022-01-28C16284748780-1d6a99b39-def5-a426-e053-dadaa90af4c2a6a57d68-c99d-977a-e053-2995a90a817f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78342-001-01Hand Sanitizer500 mL in 1 BOTTLEGEL5002
78342-001-02Hand Sanitizer1000 mL in 1 BOTTLEGEL10002
78342-001-03Hand Sanitizer20000 mL in 1 CONTAINERGEL200002
78342-001-04Hand Sanitizer1000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL10000002
78342-002-01Hand Sanitizer500 mL in 1 BOTTLEGEL5002
78342-002-02Hand Sanitizer1000 mL in 1 BOTTLEGEL10002
78342-002-03Hand Sanitizer20000 mL in 1 CONTAINERGEL200002
78342-002-04Hand Sanitizer1000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL10000002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78342-001HAND SANITIZER (ALCOHOL) GEL [QUÍMICA BLANTEX, S.A. DE C.V.]2Legacy NDC, 4 package rows20200722_a6a57d68-c99d-977a-e053-2995a90a817f.zip
78342-002HAND SANITIZER (ALCOHOL) GEL [QUÍMICA BLANTEX, S.A. DE C.V.]2Legacy NDC, 4 package rows20200722_a6a57d68-c99d-977a-e053-2995a90a817f.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78342-00178342-001-01, 78342-001-03, 78342-001-04, 78342-001-02
78342-00278342-002-01, 78342-002-03, 78342-002-04, 78342-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT

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
aaf71f9f-ac59-af69-e053-2995a90a60d8a6a57d68-c99d-977a-e053-2995a90a817f2020-07-21WarningsExact identifier
spl id: aaf71f9f-ac59-af69-e053-2995a90a60d8
spl set id: a6a57d68-c99d-977a-e053-2995a90a817f

Reported adverse events (FAERS/openFDA)#

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