FDA.reportPublic FDA data

ANTIBACTERIAL HAND SANITIZING GEL

Manufacturer
Grupo Rodeh S.A. de C.V.
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:18:07

Label at a glance#

ProductANTIBACTERIAL HAND SANITIZING
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Apply. Put enough product on hands to cover all surfaces. Rub hands together, until hands feel dry. This should take around 20 seconds.  recommended for repeated use.  Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • Antibacterial hand sanitizing gel to help killing bacteria and germs as antiseptic on the skin. For use when soap and water are not available.

Warnings

WARNINGS SECTION

e. Keep away from fire or flame. Flammabl

For external use only

When using this product

OTC - WHEN USING SECTION

keep out of eyes and mouth. In case of contact with eyes, immediately rinse eyes thoroughly with water

Stop use and ask doctor

OTC - STOP USE SECTION

If irritation, rash or allergy occurs. These may be signs of a serious condition

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a poison control center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply. Put enough product on hands to cover all surfaces. Rub hands together, until hands feel dry. This should take around 20 seconds.  recommended for repeated use.
  •  Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

OTHER SAFETY INFORMATION

• Store between 59-86ºF (15-30ºC) avoid freezing and excessive heat above 104ºF (40ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

• Deionized Water. Carbomer. Panthenol. D-Limonene. DMDM Hydantoin. Disodium EDTA Triethanolamine.

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77710-001-002023-12-13C16284748780-1d6a99b39-c066-a426-e053-dadaa90af4c2ANTIBACTERIAL HAND SANITIZING GEL
77710-001-002022-01-28C16284748780-1d6a99b39-c066-a426-e053-dadaa90af4c2ANTIBACTERIAL HAND SANITIZING GEL

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77710-00177710-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PANTHENOLWV9CM0O67ZIACT
LIMONENE, (+)-GFD7C86Q1WIACT
DMDM HYDANTOINBYR0546TOWIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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
14bb17dc-22fb-dc90-e063-6294a90a604fa5eaf1ba-b2d3-229f-e053-2995a90a7aa32024-03-28WarningsExact identifier
spl set id: a5eaf1ba-b2d3-229f-e053-2995a90a7aa3

Reported adverse events (FAERS/openFDA)#

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