FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION
Effective date
2020-04-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:08:51

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 rub hand sanitizer (leave in product) which is intended to be used when soap and water are not available, and are left on and not rinsed off with water. It complies with the final rule on consumer antiseptic rubs, using alcohol in a percentage between 65 and 90%. The product is made with

  1. Alcohol (ethanol) (70%, volume/volume (v/v)) in an aqueous solution denatured.
  2. Glycerol (10% v/v).
  3. Isopropyl alcohol (1.33% v/v).
  4. Sterile distilled water or boiled cold water.
  5. Carbomer 940 (0.25% m/v)
  6. Polysorbate 20 (3.33% m/v)

The firm add only fragrance (0.002%) as an inactive ingredient, and realizes it 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, 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, isopropyl alcohol, carbopol 940, polysorbate 20, fragrance, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL NDC: 76540-100-01 Hand SanitizerHand Sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN4
581662ethanol 0.7 ML/ML Topical GelSCD4
581662ethanol 70 % Topical GelSY4
581662ethyl alcohol 70 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76938-100-022022-01-28C16284748780-1d6a99b39-a4c5-a426-e053-dadaa90af4c2a45cf83f-ec35-643d-e053-2a95a90ad8a6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76938-100-02Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICGEL10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76938-100HAND SANITIZER (ALCOHOL) GEL [GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION]4Legacy NDC, 1 package rows20200430_a45cf83f-ec35-643d-e053-2a95a90ad8a6.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
76938-10076938-100-02

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
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
THIOGLYCOLIC ACID TRIETHANOLAMINEJPH0S6Q77RIACT
POLYSORBATE 207T1F30V5YHIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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
a45cfd18-cfa4-6435-e053-2a95a90af284a45cf83f-ec35-643d-e053-2a95a90ad8a62020-04-28WarningsExact identifier
spl id: a45cfd18-cfa4-6435-e053-2a95a90af284
spl set id: a45cf83f-ec35-643d-e053-2a95a90ad8a6

Reported adverse events (FAERS/openFDA)#

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