FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
SERVICIOS INTEGRADOS DE ENVASADO SA DE CV
Effective date
2020-06-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:15:37

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

purified water USP, glycerin, carbomer, triethanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL NDC: 77252-003-01 Kingspoint Gel 70% 500 mLKingspoint Gel 70% 500 mL

Urgent RN 70% 500 mLUrgent RN 70% 500 mL

1000 mL NDC: 77252-003-02

Kingspoint 500mLKingspoint 500mL

SIEGEL1LSIEGEL1L

4000 mL NDC: 77252-003-03 etiqueta 4Letiqueta 4L

3780mL NDC 77252-003-04

SIEGEL1GALSIEGEL1GAL

60mL NDC 77252-003-05

Medply 60mL PDPMedply 60mL PDP

Medply 60 mL IPMedply 60 mL IP

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
77252-003-012022-01-28C16284748780-1d6a99b39-73e5-a426-e053-dadaa90af4c2a64134d5-e6b7-3b61-e053-2a95a90a7013
77252-003-022022-01-28C16284748780-1d6a99b39-73e5-a426-e053-dadaa90af4c2a64134d5-e6b7-3b61-e053-2a95a90a7013
77252-003-032022-01-28C16284748780-1d6a99b39-73e5-a426-e053-dadaa90af4c2a64134d5-e6b7-3b61-e053-2a95a90a7013
77252-003-042022-01-28C16284748780-1d6a99b39-73e5-a426-e053-dadaa90af4c2a64134d5-e6b7-3b61-e053-2a95a90a7013
77252-003-052022-01-28C16284748780-1d6a99b39-73e5-a426-e053-dadaa90af4c2a64134d5-e6b7-3b61-e053-2a95a90a7013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77252-003-01Hand Sanitizer500 mL in 1 BOTTLEGEL5003
77252-003-02Hand Sanitizer1000 mL in 1 BOTTLEGEL10003
77252-003-03Hand Sanitizer4000 mL in 1 BOTTLEGEL40003
77252-003-04Hand Sanitizer3780 mL in 1 BOTTLEGEL37803
77252-003-05Hand Sanitizer60 mL in 1 BOTTLEGEL603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77252-003HAND SANITIZER (ALCOHOL) GEL [SERVICIOS INTEGRADOS DE ENVASADO SA DE CV]3Legacy NDC, 5 package rows20200602_a64134d5-e6b7-3b61-e053-2a95a90a7013.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
77252-00377252-003-01, 77252-003-02, 77252-003-03, 77252-003-04, 77252-003-05

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
CARBOMER 9404Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
TRIETHANOLAMINE HYDRIODIDEDT98IT03JKIACT
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
a70e39a5-bfef-9d0c-e053-2995a90ac347a64134d5-e6b7-3b61-e053-2a95a90a70132020-06-01WarningsExact identifier
spl id: a70e39a5-bfef-9d0c-e053-2995a90ac347
spl set id: a64134d5-e6b7-3b61-e053-2a95a90a7013

Reported adverse events (FAERS/openFDA)#

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