FDA.reportPublic FDA data

Solution

Manufacturer
HONNES SAGLIK VE ENDUSTRIYEL URUNLERI ANONIM SIRKETI | HARDAL GLOBAL CONSULTING LLC
Effective date
2020-07-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:38

Label at a glance#

ProductB-GOOD HAND AND SKIN DISINFECTING AGENT
Active ingredientCHLORHEXIDINE GLUCONATE, ALCOHOL
Label structure13 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#

DESCRIPTION SECTION

B-GOOD HAND AND SKIN DISINFECTING AGENT (ANTISEPTIC SOLUTION)

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Clorhexidine Digluconate 4%, Ethanol 10%

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.

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

Glycerine, Preservative, Deionized water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Producer

HONNES SAGLIK VE ENDUSTRIYEL URUNLERI A.S.

Cumhuriyet Mh. Karayel Sk. No:14 41420

Cayirova/KOCAELI/TURKEY

Tel.: +90 262 658 89 59

Fax: +90 262 658 80 40

www.honnes.com / info@honnes.com

T.C. SAGLIK BAKANLIGI'NIN 09.08.2019 Tarihi ve 2019/97 No'lu Izniyle Uretilmistir.

LICENSE HOLDER: HONNES SAGLIK VE ENDUSTRIYEL URUNLERI A.S.

LICENCE DATE AND NUMBER 09.08.2019-2019/97

ATTENTION, CAN BE USED EXTERNALLY, DO NOT DRINK

Use the unpacked product within 6 months. The shelf life of the product is 2 years with its mouth closed, in a cool and dry place.

SOLUTIONSOLUTION

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79129-003-012022-01-28C16284748780-1d6a99b39-4dc4-a426-e053-dadaa90af4c2Solution
79129-003-022022-01-28C16284748780-1d6a99b39-4dc4-a426-e053-dadaa90af4c2Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79129-003-01B-GOOD HAND AND SKIN DISINFECTING AGENT100 mL in 1 BOTTLE, PLASTICSOLUTION1001
79129-003-02B-GOOD HAND AND SKIN DISINFECTING AGENT1000 mL in 1 BOTTLE, PLASTICSOLUTION10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79129-003B-GOOD HAND AND SKIN DISINFECTING AGENT (ALCOHOL) SOLUTION [HONNES SAGLIK VE ENDUSTRIYEL URUNLERI ANONIM SIRKETI]1Legacy NDC, 2 package rows20200709_a98ea8b6-b6a2-1e9c-e053-2a95a90a5e4e.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
79129-00379129-003-01, 79129-003-02

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
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB
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
a98ea8b6-b694-1e9c-e053-2a95a90a5e4ea98ea8b6-b6a2-1e9c-e053-2a95a90a5e4e2020-07-03WarningsExact identifier
spl id: a98ea8b6-b694-1e9c-e053-2a95a90a5e4e
spl set id: a98ea8b6-b6a2-1e9c-e053-2a95a90a5e4e

Reported adverse events (FAERS/openFDA)#

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