FDA.reportPublic FDA data

iBrite Hand Sanitizer

Manufacturer
Gingi-Pak
Effective date
2020-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:07

Label at a glance#

ProductiBrite Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Dispense enough gel in your palm to cover all surfaces of hands and finger. Rub hands together vigorously until dry. Usage on children requires adult supervision, not recommended for infants. Work best on clean and dry hands.

Storage and handling

Store below 43 C (110F) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Reduce bacteria that potentially can cause disease.

Recommened for repeated use

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

Do not apply around eyes.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • Avoid contact with broken skin.
  • Do not inhale or ingest.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or rash 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

  • Dispense enough gel in your palm to cover all surfaces of hands and finger. Rub hands together vigorously until dry.
  • Usage on children requires adult supervision, not recommended for infants.
  • Work best on clean and dry hands.

Other information

STORAGE AND HANDLING SECTION

  • Store below 43 C (110F)
  • May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Distilled Water, Glycerin, Carbomer 940, Benzophenone-4, Aloe Vera, Aminomethyl Propanol.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal display- 16 ozPrincipal display- 16 ozPrincipal Display- 2 ozPrincipal Display- 2 oz

Principal Display- 8 ozPrincipal Display- 8 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10129-080-012025-01-30C16284748780-1c7ccaba7-1aa0-fd44-e053-dadaa90aa01biBrite Hand Sanitizer
10129-080-022025-01-30C16284748780-1c7ccaba7-1aa0-fd44-e053-dadaa90aa01biBrite Hand Sanitizer
10129-080-032025-01-30C16284748780-1c7ccaba7-1aa0-fd44-e053-dadaa90aa01biBrite Hand Sanitizer
10129-080-012021-09-02C16284748780-1c7ccaba7-1aa0-fd44-e053-dadaa90aa01biBrite Hand Sanitizer
10129-080-022021-09-02C16284748780-1c7ccaba7-1aa0-fd44-e053-dadaa90aa01biBrite Hand Sanitizer
10129-080-032021-09-02C16284748780-1c7ccaba7-1aa0-fd44-e053-dadaa90aa01biBrite Hand Sanitizer
10129-080-012021-07-23C16284748780-1c7ccaba7-1aa0-fd44-e053-dadaa90aa01biBrite Hand Sanitizer
10129-080-022021-07-23C16284748780-1c7ccaba7-1aa0-fd44-e053-dadaa90aa01biBrite Hand Sanitizer
10129-080-032021-07-23C16284748780-1c7ccaba7-1aa0-fd44-e053-dadaa90aa01biBrite Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10129-080-01iBrite Hand Sanitizer59 mL in 1 BOTTLE, DISPENSINGGEL591
10129-080-02iBrite Hand Sanitizer472 mL in 1 BOTTLE, DISPENSINGGEL4721
10129-080-03iBrite Hand Sanitizer250 mL in 1 BOTTLE, DISPENSINGGEL2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10129-080IBRITE HAND SANITIZER (ETHYL ALCOHOL) GEL [GINGI-PAK]1Legacy NDC, 3 package rows20200414_a21745b5-c65b-05ce-e053-2a95a90acfc2.zip

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
10129-08010129-080-01, 10129-080-02, 10129-080-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULISOBENZONE1W6L629B4KIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT

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
a21744dd-b5f7-0594-e053-2a95a90a19fba21745b5-c65b-05ce-e053-2a95a90acfc22020-04-10WarningsExact identifier
spl id: a21744dd-b5f7-0594-e053-2a95a90a19fb
spl set id: a21745b5-c65b-05ce-e053-2a95a90acfc2

Reported adverse events (FAERS/openFDA)#

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