FDA.reportPublic FDA data

Pure Carnation

Manufacturer
Eng Kah Enterprise Sdn.Bhd | Eng Kah Enterprise Sdn.Bhd.
Effective date
2020-06-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:17

Label at a glance#

ProductPure Carnation
Active ingredientALCOHOL
Label structure9 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 in cool, dry place (below 30 0 C) and protect from heat. Must put in upright position.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 77% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

INDICATIONS & USAGE SECTION

Health care personnel hand rub used to eliminate infectious germs that can cause diseases immediately and effectively.

Warnings

WARNINGS SECTION

For external use only...

Flammable. Keep away from heat or flame...

Do not use:

  • In children less than 2 years old.
  • On open skin wound.

When using this product keep out 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.

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 in cool, dry place (below 300C) and protect from heat. Must put in upright position.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Carbomer, Fragrance, Punica Granatum Extract, Triethanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1Label 1

Label 2Label 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42498-001-012023-01-30C16284748780-1f386c649-d138-0266-e053-dadaa90a7c1a6b476122-c870-4e09-90ed-24d62d49ca41
42498-001-022023-01-30C16284748780-1f386c649-d138-0266-e053-dadaa90a7c1a6b476122-c870-4e09-90ed-24d62d49ca41
42498-001-032023-01-30C16284748780-1f386c649-d138-0266-e053-dadaa90a7c1a6b476122-c870-4e09-90ed-24d62d49ca41
42498-001-042023-01-30C16284748780-1f386c649-d138-0266-e053-dadaa90a7c1a6b476122-c870-4e09-90ed-24d62d49ca41
42498-001-052023-01-30C16284748780-1f386c649-d138-0266-e053-dadaa90a7c1a6b476122-c870-4e09-90ed-24d62d49ca41
42498-001-062023-01-30C16284748780-1f386c649-d138-0266-e053-dadaa90a7c1a6b476122-c870-4e09-90ed-24d62d49ca41
42498-001-072023-01-30C16284748780-1f386c649-d138-0266-e053-dadaa90a7c1a6b476122-c870-4e09-90ed-24d62d49ca41
42498-001-082023-01-30C16284748780-1f386c649-d138-0266-e053-dadaa90a7c1a6b476122-c870-4e09-90ed-24d62d49ca41
42498-001-092023-01-30C16284748780-1f386c649-d138-0266-e053-dadaa90a7c1a6b476122-c870-4e09-90ed-24d62d49ca41
42498-001-102023-01-30C16284748780-1f386c649-d138-0266-e053-dadaa90a7c1a6b476122-c870-4e09-90ed-24d62d49ca41
42498-001-112023-01-30C16284748780-1f386c649-d138-0266-e053-dadaa90a7c1a6b476122-c870-4e09-90ed-24d62d49ca41

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42498-001-01Pure Carnation50 mL in 1 BOTTLEGEL501
42498-001-02Pure Carnation60 mL in 1 BOTTLEGEL601
42498-001-03Pure Carnation120 mL in 1 BOTTLEGEL1201
42498-001-04Pure Carnation250 mL in 1 BOTTLEGEL2501
42498-001-05Pure Carnation500 mL in 1 BOTTLEGEL5001
42498-001-06Pure Carnation600 mL in 1 BOTTLEGEL6001
42498-001-07Pure Carnation750 mL in 1 BOTTLEGEL7501
42498-001-08Pure Carnation1000 mL in 1 BOTTLEGEL10001
42498-001-09Pure Carnation5000 mL in 1 BOTTLEGEL50001
42498-001-10Pure Carnation20000 mL in 1 BOTTLEGEL200001
42498-001-11Pure Carnation25000 mL in 1 BOTTLEGEL250001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42498-001PURE CARNATION (ALCOHOL) GEL [ENG KAH ENTERPRISE SDN.BHD]1Legacy NDC, 11 package rows20200612_6b476122-c870-4e09-90ed-24d62d49ca41.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42498-00142498-001-01, 42498-001-02, 42498-001-03, 42498-001-04, 42498-001-05, 42498-001-06, 42498-001-07, 42498-001-08, 42498-001-09, 42498-001-10, 42498-001-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT

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
5f5f04ac-3ffb-4ed2-a33b-dbdbb2fcf1406b476122-c870-4e09-90ed-24d62d49ca412020-06-10WarningsExact identifier
spl id: 5f5f04ac-3ffb-4ed2-a33b-dbdbb2fcf140
spl set id: 6b476122-c870-4e09-90ed-24d62d49ca41

Reported adverse events (FAERS/openFDA)#

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