FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Jorge Martin Gomez Sanchez
Effective date
2020-08-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:24:34

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 hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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 aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Sterile distilled water or boiled cold water.
  3. Isopropyl Alcohol
  4. Carbomer 940
  5. Glycerin
  6. Triethanolamine
  7. Aloe Vera Leaf extract.

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, 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

Purified water USP, isopropyl alcohol, carbomer 940, glycerin, triethanolamine, aloe vera extract.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL NDC: 78471-005-01

Hand sanitizer 1 LHand sanitizer 1 L

3780 mL NDC: 78471-005-02

Hand sanitizer 3.78 LHand sanitizer 3.78 L5000 mL NDC: 78471-005-03

Hand sanitizer 5 LHand sanitizer 5 L

19000 mL NDC: 78471-005-04

Hand sanitizer 19 LHand sanitizer 19 L

120 mL NDC: 78471-005-05

Hand sanitizer 120 mLHand sanitizer 120 mL

250 mL NDC: 78471-005-06

Hand sanitizer 250 mLHand sanitizer 250 mL500 mL NDC: 78471-005-07

Hand sanitizer 500 mLHand sanitizer 500 mL1000000 mL NDC: 78471-005-08

Hand sanitizer 1000 LHand sanitizer 1000 L

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
78471-005-012022-01-28C16284748780-1d6a99b39-adb3-a426-e053-dadaa90af4c2HAND SANITIZER
78471-005-022022-01-28C16284748780-1d6a99b39-adb3-a426-e053-dadaa90af4c2HAND SANITIZER
78471-005-032022-01-28C16284748780-1d6a99b39-adb3-a426-e053-dadaa90af4c2HAND SANITIZER
78471-005-042022-01-28C16284748780-1d6a99b39-adb3-a426-e053-dadaa90af4c2HAND SANITIZER
78471-005-052022-01-28C16284748780-1d6a99b39-adb3-a426-e053-dadaa90af4c2HAND SANITIZER
78471-005-062022-01-28C16284748780-1d6a99b39-adb3-a426-e053-dadaa90af4c2HAND SANITIZER
78471-005-072022-01-28C16284748780-1d6a99b39-adb3-a426-e053-dadaa90af4c2HAND SANITIZER
78471-005-082022-01-28C16284748780-1d6a99b39-adb3-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78471-005-01Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICGEL10002
78471-005-02Hand Sanitizer3780 mL in 1 BOTTLE, PLASTICGEL37802
78471-005-03Hand Sanitizer5000 mL in 1 BOTTLE, PLASTICGEL50002
78471-005-04Hand Sanitizer19000 mL in 1 PAILGEL190002
78471-005-05Hand Sanitizer120 mL in 1 BOTTLE, PLASTICGEL1202
78471-005-06Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2502
78471-005-07Hand Sanitizer500 mL in 1 BOTTLE, PLASTICGEL5002
78471-005-08Hand Sanitizer1000000 mL in 1 DRUMGEL10000002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78471-005HAND SANITIZER (ALCOHOL) GEL [JORGE MARTIN GOMEZ SANCHEZ]2Legacy NDC, 8 package rows20200813_abc10a96-4b83-a2d3-e053-2a95a90aec7a.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78471-00578471-005-01, 78471-005-02, 78471-005-03, 78471-005-04, 78471-005-05, 78471-005-06, 78471-005-07, 78471-005-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE)36YHT392IDIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
ac9fc932-fb5e-9872-e053-2995a90ab488abc10a96-4b83-a2d3-e053-2a95a90aec7a2020-08-11WarningsExact identifier
spl id: ac9fc932-fb5e-9872-e053-2995a90ab488
spl set id: abc10a96-4b83-a2d3-e053-2a95a90aec7a

Reported adverse events (FAERS/openFDA)#

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