FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Octapod, S.A de C.V.
Effective date
2020-09-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:29:54

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 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 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

water, glycerin, carbomer, triethanolamine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP 60mL NDC:78800-002-01 PDP 60 mLPDP 60 mLPI 60mL NDC:78800-002-01

PI 60 mLPI 60 mLPDP 125 mL NDC:78800-002-02 PDP 25 mLPDP 25 mLPDP 250 mL NDC:78800-002-03 PDP 250 mLPDP 250 mLPDP 500mL NDC:78800-002-04 PDP 500 mLPDP 500 mLPDP 1000mL NDC:78800-002-05 PDP 1000 mLPDP 1000 mLPDP 3785 mL NDC:78800-002-06 PDP 3785 mLPDP 3785 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78800-002-012022-01-28C16284748780-1d6a99b39-e34e-a426-e053-dadaa90af4c2a798a17f-8b04-250e-e053-2995a90a023d
78800-002-022022-01-28C16284748780-1d6a99b39-e34e-a426-e053-dadaa90af4c2a798a17f-8b04-250e-e053-2995a90a023d
78800-002-032022-01-28C16284748780-1d6a99b39-e34e-a426-e053-dadaa90af4c2a798a17f-8b04-250e-e053-2995a90a023d
78800-002-042022-01-28C16284748780-1d6a99b39-e34e-a426-e053-dadaa90af4c2a798a17f-8b04-250e-e053-2995a90a023d
78800-002-052022-01-28C16284748780-1d6a99b39-e34e-a426-e053-dadaa90af4c2a798a17f-8b04-250e-e053-2995a90a023d
78800-002-062022-01-28C16284748780-1d6a99b39-e34e-a426-e053-dadaa90af4c2a798a17f-8b04-250e-e053-2995a90a023d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78800-002-01Hand Sanitizer60 mL in 1 BOTTLEGEL603
78800-002-02Hand Sanitizer125 mL in 1 BOTTLEGEL1253
78800-002-03Hand Sanitizer250 mL in 1 BOTTLEGEL2503
78800-002-04Hand Sanitizer500 mL in 1 BOTTLEGEL5003
78800-002-05Hand Sanitizer1000 mL in 1 BOTTLEGEL10003
78800-002-06Hand Sanitizer3785 mL in 1 BOTTLEGEL37853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78800-002HAND SANITIZER (ALCOHOL) GEL [OCTAPOD, S.A DE C.V.]3Legacy NDC, 6 package rows20200923_a798a17f-8b04-250e-e053-2995a90a023d.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
78800-00278800-002-01, 78800-002-02, 78800-002-03, 78800-002-04, 78800-002-05, 78800-002-06

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
CARBOMER 1342809Y72KV36IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TRIETHANOLAMINE HYDRIODIDEDT98IT03JKIACT

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
af5c0244-fd2b-30ad-e053-2995a90ae8e3a798a17f-8b04-250e-e053-2995a90a023d2020-09-15WarningsExact identifier
spl id: af5c0244-fd2b-30ad-e053-2995a90ae8e3
spl set id: a798a17f-8b04-250e-e053-2995a90a023d

Reported adverse events (FAERS/openFDA)#

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