FDA.reportPublic FDA data

ChemBrite

Manufacturer
Interion Pte Ltd
Effective date
2020-05-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:10

Label at a glance#

ProductChemBrite
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

Dosage and administration

Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using products.

Storage and handling

Store below 110°F(43C°) Avoid freezing and excessive heat above 40C (104F) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 60% 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

  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using products.

Other information

STORAGE AND HANDLING SECTION

Store below 110°F(43C°)
Avoid freezing and excessive heat above 40C (104F)

May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Carboxymethyl Cellulose, Denatonium Benzoate, Glycerin, Lemon peel oil, Monopropylene Glycol, PEG-6000 Dilaurate, Purified Water, Triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200 ml NDC: 78036-001-01200 ml NDC: 78036-001-01

200 ml NDC: 78036-001-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2371247isopropyl alcohol 60 % Topical GelPSN1
2371247isopropyl alcohol 0.6 ML/ML Topical GelSCD1
2371247isopropyl alcohol 60 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78036-001-012022-01-28C16284748780-1d6a99b39-a6e9-a426-e053-dadaa90af4c2Interion 60% IPA
78036-001-022022-01-28C16284748780-1d6a99b39-a6e9-a426-e053-dadaa90af4c2Interion 60% IPA
78036-001-032022-01-28C16284748780-1d6a99b39-a6e9-a426-e053-dadaa90af4c2Interion 60% IPA
78036-001-042022-01-28C16284748780-1d6a99b39-a6e9-a426-e053-dadaa90af4c2Interion 60% IPA
78036-001-052022-01-28C16284748780-1d6a99b39-a6e9-a426-e053-dadaa90af4c2Interion 60% IPA
78036-001-062022-01-28C16284748780-1d6a99b39-a6e9-a426-e053-dadaa90af4c2Interion 60% IPA
78036-001-072022-01-28C16284748780-1d6a99b39-a6e9-a426-e053-dadaa90af4c2Interion 60% IPA
78036-001-082022-01-28C16284748780-1d6a99b39-a6e9-a426-e053-dadaa90af4c2Interion 60% IPA
78036-001-092022-01-28C16284748780-1d6a99b39-a6e9-a426-e053-dadaa90af4c2Interion 60% IPA
78036-001-102022-01-28C16284748780-1d6a99b39-a6e9-a426-e053-dadaa90af4c2Interion 60% IPA
78036-001-112022-01-28C16284748780-1d6a99b39-a6e9-a426-e053-dadaa90af4c2Interion 60% IPA
78036-001-122022-01-28C16284748780-1d6a99b39-a6e9-a426-e053-dadaa90af4c2Interion 60% IPA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78036-001-01ChemBrite200 mL in 1 BOTTLEGEL2001
78036-001-02ChemBrite250 mL in 1 BOTTLEGEL2501
78036-001-03ChemBrite500 mL in 1 BOTTLEGEL5001
78036-001-04ChemBrite1000 mL in 1 BOTTLEGEL10001
78036-001-05ChemBrite5000 mL in 1 CONTAINERGEL50001
78036-001-06ChemBrite10000 mL in 1 CONTAINERGEL100001
78036-001-07ChemBrite20000 mL in 1 CONTAINERGEL200001
78036-001-08ChemBrite25000 mL in 1 CONTAINERGEL250001
78036-001-09ChemBrite30000 mL in 1 CONTAINERGEL300001
78036-001-10ChemBrite200000 mL in 1 CONTAINERGEL2000001
78036-001-11ChemBrite209000 mL in 1 CONTAINERGEL2090001
78036-001-12ChemBrite1000000 mL in 1 CONTAINERGEL10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78036-001CHEMBRITE (HAND SANITIZER) GEL [INTERION PTE LTD]1Legacy NDC, 12 package rows20200529_a6b281df-665d-cc94-e053-2995a90a0da6.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78036-00178036-001-01, 78036-001-02, 78036-001-03, 78036-001-04, 78036-001-05, 78036-001-06, 78036-001-07, 78036-001-08, 78036-001-09, 78036-001-10, 78036-001-11, 78036-001-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
PEG-150 DILAURATECF607I8E19IACT
BENZYL ALCOHOLLKG8494WBHIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
LEMON OIL, TERPENELESSX69W83NI7VIACT

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
a6b26db8-dda7-8449-e053-2995a90a7207a6b281df-665d-cc94-e053-2995a90a0da62020-05-28WarningsExact identifier
spl id: a6b26db8-dda7-8449-e053-2995a90a7207
spl set id: a6b281df-665d-cc94-e053-2995a90a0da6

Reported adverse events (FAERS/openFDA)#

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