FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Rodríguez Fierro, Marco Antonio | Mario Hidalgo
Effective date
2020-06-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:38

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure16 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

Alcohol 75% 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, carbomer 940, trolamine, purified water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 250 mLLabel 250 mL250 mL NDC: 78368-577-17

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1000 mLLabel 1000 mL1000 mL NDC: 78368-577-18

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 3785 mLLabel 3785 mL3785 mL NDC: 78368-577-19

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 20000 mLLabel 20000 mL20000 mL NDC: 78368-577-20

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 200000 mLLabel 200000 mL200000 mL NDC: 78368-577-21

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78368-577-172022-01-28C16284748780-1d6a99b39-a8b4-a426-e053-dadaa90af4c2Hand Sanitizer
78368-577-182022-01-28C16284748780-1d6a99b39-a8b4-a426-e053-dadaa90af4c2Hand Sanitizer
78368-577-192022-01-28C16284748780-1d6a99b39-a8b4-a426-e053-dadaa90af4c2Hand Sanitizer
78368-577-202022-01-28C16284748780-1d6a99b39-a8b4-a426-e053-dadaa90af4c2Hand Sanitizer
78368-577-212022-01-28C16284748780-1d6a99b39-a8b4-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78368-577-17Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2501
78368-577-18Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICGEL10001
78368-577-19Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICGEL37851
78368-577-20Hand Sanitizer20000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL200001
78368-577-21Hand Sanitizer200000 mL in 1 DRUMGEL2000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78368-577HAND SANITIZER (ALCOHOL) GEL [RODRÍGUEZ FIERRO, MARCO ANTONIO]1Legacy NDC, 5 package rows20200609_a78ba73b-aaa7-919e-e053-2a95a90a1035.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
78368-57778368-577-17, 78368-577-18, 78368-577-19, 78368-577-20, 78368-577-21

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
CARBOMER 9404Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a78ba73b-aa99-919e-e053-2a95a90a1035a78ba73b-aaa7-919e-e053-2a95a90a10352020-06-08WarningsExact identifier
spl id: a78ba73b-aa99-919e-e053-2a95a90a1035
spl set id: a78ba73b-aaa7-919e-e053-2a95a90a1035

Reported adverse events (FAERS/openFDA)#

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