FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Ignacio Reyes González
Effective date
2020-05-26
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:14:43

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

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an Gel solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (0.52% v/v).
  3. Hydroxyethyl Cellulose (0.86% v/v).
  4. Trolamine (0.12% v/v).
  5. Sterile distilled water or boiled cold water.

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, hydroxyethyl cellulose, trolamine, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200000 mL NDC: 77196-002-02 200000 mL Labels200000 mL Labels

1000 mL NDC: 77196-002-05 1000 mL Labels1000 mL Labels

500 mL NDC: 77196-002-06 500 mL Labels500 mL Labels

250 mL NDC: 77196-002-07 250 mL Labels250 mL Labels

110 mL NDC: 77196-002-08 110 mL Labels110 mL Labels

20000 mL NDC: 77196-002-03 20000 mL Labels20000 mL Labels

1000000 mL NDC: 77196-002-01 1000000 mL Labels1000000 mL Labels

220 mL NDC: 77196-002-09 220 mL Labels220 mL Labels

60 mL NDC: 77196-002-10 60 mL Labels60 mL Labels

4000 mL NDC: 77196-002-04 4000 mL Labels4000 mL Labels

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77196-002-012022-01-28C16284748780-1d6a99b39-f3a4-a426-e053-dadaa90af4c2Hand Sanitizer
77196-002-022022-01-28C16284748780-1d6a99b39-f3a4-a426-e053-dadaa90af4c2Hand Sanitizer
77196-002-032022-01-28C16284748780-1d6a99b39-f3a4-a426-e053-dadaa90af4c2Hand Sanitizer
77196-002-042022-01-28C16284748780-1d6a99b39-f3a4-a426-e053-dadaa90af4c2Hand Sanitizer
77196-002-052022-01-28C16284748780-1d6a99b39-f3a4-a426-e053-dadaa90af4c2Hand Sanitizer
77196-002-062022-01-28C16284748780-1d6a99b39-f3a4-a426-e053-dadaa90af4c2Hand Sanitizer
77196-002-072022-01-28C16284748780-1d6a99b39-f3a4-a426-e053-dadaa90af4c2Hand Sanitizer
77196-002-082022-01-28C16284748780-1d6a99b39-f3a4-a426-e053-dadaa90af4c2Hand Sanitizer
77196-002-092022-01-28C16284748780-1d6a99b39-f3a4-a426-e053-dadaa90af4c2Hand Sanitizer
77196-002-102022-01-28C16284748780-1d6a99b39-f3a4-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77196-002-01Hand Sanitizer1000000 mL in 1 TANKGEL10000006
77196-002-02Hand Sanitizer200000 mL in 1 DRUMGEL2000006
77196-002-03Hand Sanitizer20000 mL in 1 CONTAINERGEL200006
77196-002-04Hand Sanitizer4000 mL in 1 BOTTLE, DISPENSINGGEL40006
77196-002-05Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICGEL10006
77196-002-06Hand Sanitizer500 mL in 1 BOTTLE, PLASTICGEL5006
77196-002-07Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2506
77196-002-08Hand Sanitizer110 mL in 1 BOTTLE, PLASTICGEL1106
77196-002-09Hand Sanitizer220 mL in 1 BOTTLE, PLASTICGEL2206
77196-002-10Hand Sanitizer60 mL in 1 BOTTLE, PLASTICGEL606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77196-002HAND SANITIZER (ALCOHOL) GEL [IGNACIO REYES GONZÁLEZ]6Legacy NDC, 10 package rows20200527_a54d685b-f630-eb2b-e053-2995a90ae29a.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
77196-00277196-002-02, 77196-002-05, 77196-002-06, 77196-002-07, 77196-002-08, 77196-002-01, 77196-002-03, 77196-002-09, 77196-002-10, 77196-002-04

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
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT

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
a6917bff-b5e2-1304-e053-2995a90ada95a54d685b-f630-eb2b-e053-2995a90ae29a2020-05-26WarningsExact identifier
spl id: a6917bff-b5e2-1304-e053-2995a90ada95
spl set id: a54d685b-f630-eb2b-e053-2995a90ae29a

Reported adverse events (FAERS/openFDA)#

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