FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Laboratorio Salutec, S.A. de C.V.
Effective date
2020-07-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:22:48

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 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#

SPL UNCLASSIFIED SECTION

This is a gel hand sanitizer

The gel hand sanitizer is manufactured using only the following ingredients consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1% v/v).
  3. Sterile distilled water or boiled cold water.
    d. Carbomer
    e. Trolamine

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Gel Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Gel 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

Carbomer, Water, Trolamine, Glycerin

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 mL NDC: 79289-001-01 Front LabelFront Label Back LabelBack Label


500 mL NDC: 79289-001-05
FRONT LABELFRONT LABEL BACK LABELBACK LABEL

4000 mL NDC: 79289-001-04
FRONT LABELFRONT LABEL BACK LABELBACK LABEL

125 mL NDC: 79289-001-03
FRONT LABELFRONT LABEL BACK LABELBACK LABEL

1000 mL NDC: 79289-001-02
FRONT LABELFRONT LABEL BACK LABELBACK LABEL

60 mL NDC: 79289-001-06 Front LabelFront Label
BACK LABELBACK LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79289-001-012022-01-28C16284748780-1d6a99b39-c5df-a426-e053-dadaa90af4c2a8b252cc-ef4e-d876-e053-2995a90a03a4
79289-001-022022-01-28C16284748780-1d6a99b39-c5df-a426-e053-dadaa90af4c2a8b252cc-ef4e-d876-e053-2995a90a03a4
79289-001-032022-01-28C16284748780-1d6a99b39-c5df-a426-e053-dadaa90af4c2a8b252cc-ef4e-d876-e053-2995a90a03a4
79289-001-042022-01-28C16284748780-1d6a99b39-c5df-a426-e053-dadaa90af4c2a8b252cc-ef4e-d876-e053-2995a90a03a4
79289-001-052022-01-28C16284748780-1d6a99b39-c5df-a426-e053-dadaa90af4c2a8b252cc-ef4e-d876-e053-2995a90a03a4
79289-001-062022-01-28C16284748780-1d6a99b39-c5df-a426-e053-dadaa90af4c2a8b252cc-ef4e-d876-e053-2995a90a03a4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79289-001-01Hand Sanitizer250 mL in 1 BOTTLEGEL2504
79289-001-02Hand Sanitizer1000 mL in 1 BOTTLEGEL10004
79289-001-03Hand Sanitizer125 mL in 1 BOTTLEGEL1254
79289-001-04Hand Sanitizer4000 mL in 1 BOTTLEGEL40004
79289-001-05Hand Sanitizer500 mL in 1 BOTTLEGEL5004
79289-001-06Hand Sanitizer60 mL in 1 BOTTLEGEL604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79289-001HAND SANITIZER (ALCOHOL) GEL [LABORATORIO SALUTEC, S.A. DE C.V.]4Legacy NDC, 6 package rows20200728_a8b252cc-ef4e-d876-e053-2995a90a03a4.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
79289-00179289-001-01, 79289-001-02, 79289-001-03, 79289-001-04, 79289-001-05, 79289-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
ab76cfdc-3f67-d5aa-e053-2a95a90a79a8a8b252cc-ef4e-d876-e053-2995a90a03a42020-07-27WarningsExact identifier
spl id: ab76cfdc-3f67-d5aa-e053-2a95a90a79a8
spl set id: a8b252cc-ef4e-d876-e053-2995a90a03a4

Reported adverse events (FAERS/openFDA)#

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