FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Combustibles del Noreste DG S de RL de CV
Effective date
2020-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:18

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 80% 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, polyacrylic acid (Carbomer), triethanolamine (Trolamine), Water.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236.56 mL NDC: 78477-001-01

Hand Sanitizer 8ozHand Sanitizer 8oz

Package label- Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473.12 mL NDC: 78477-001-02

Hand Sanitizer 16ozHand Sanitizer 16oz

Package Label- Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

946.24 mL NDC: 78477-001-03

Hand Sanitizer 32ozHand Sanitizer 32oz

Package Label- Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3780 mL NDC: 78477-001-04

Hand Sanitizer GalHand Sanitizer Gal

Package Label- Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20000 mL NDC: 78477-001-05

Hand Sanitizer BidonHand Sanitizer Bidon

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN2
1041498ethanol 0.8 ML/ML Topical GelSCD2
1041498ethanol 80 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78477-001-012022-01-28C16284748780-1d6a99b39-cf10-a426-e053-dadaa90af4c2a79be0d4-c417-48bd-e053-2a95a90a56fd
78477-001-022022-01-28C16284748780-1d6a99b39-cf10-a426-e053-dadaa90af4c2a79be0d4-c417-48bd-e053-2a95a90a56fd
78477-001-032022-01-28C16284748780-1d6a99b39-cf10-a426-e053-dadaa90af4c2a79be0d4-c417-48bd-e053-2a95a90a56fd
78477-001-042022-01-28C16284748780-1d6a99b39-cf10-a426-e053-dadaa90af4c2a79be0d4-c417-48bd-e053-2a95a90a56fd
78477-001-052022-01-28C16284748780-1d6a99b39-cf10-a426-e053-dadaa90af4c2a79be0d4-c417-48bd-e053-2a95a90a56fd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78477-001-01Hand Sanitizer236.56 mL in 1 BOTTLEGEL236.562
78477-001-02Hand Sanitizer473.12 mL in 1 BOTTLEGEL473.122
78477-001-03Hand Sanitizer946.24 mL in 1 BOTTLEGEL946.242
78477-001-04Hand Sanitizer3780 mL in 1 BOTTLEGEL37802
78477-001-05Hand Sanitizer20000 mL in 1 BOTTLEGEL200002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78477-001HAND SANITIZER (ALCOHOL) GEL [COMBUSTIBLES DEL NORESTE DG S DE RL DE CV]2Legacy NDC, 5 package rows20210101_a79be0d4-c417-48bd-e053-2a95a90a56fd.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
78477-00178477-001-01, 78477-001-02, 78477-001-03, 78477-001-04, 78477-001-05

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
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT

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
b7c54e68-32e5-6439-e053-2a95a90a1abca79be0d4-c417-48bd-e053-2a95a90a56fd2020-12-31WarningsExact identifier
spl id: b7c54e68-32e5-6439-e053-2a95a90a1abc
spl set id: a79be0d4-c417-48bd-e053-2a95a90a56fd

Reported adverse events (FAERS/openFDA)#

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