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01-797 Warszawa, Poland

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19.02.2020

CHLORHEXIDINE GLUCONATE 20% – MAY ALSO BE USED AS BIOCIDE

We are pleased to inform you about the positive decision of the European Chemicals Agency, ECHA.

The Chlorhexidine Gluconate 20% of RN Laboratories, distributed by IMPAG, has been added to the list of active substances and suppliers in accordance with Art. 95 paragraph 1 of Regulation EU No. 528/2012.

It may now also be used as a biocide.
 

Chlorhexidine Gluconate 20%

Chlorhexidine Gluconate 20% is a high quality antiseptic used for a broad field of indications.

  

Uses

 

Definition of Antiseptic (Anti-Infective Agents, Local)

 

Substances used on humans and animals that destroy harmful microorganisms or inhibit their activity.


Topical use

  • Surgical scrub and antiseptic hand rinse for healthcare personnel
  • Skin cleanser for preoperative skin preparation, skin wound and general skin cleanser for patients


Oral use

  • Oral rinse: Antibacterial dental rinse for gingivitis treatment
  • Against periodontitis


Veterinary use

  • Effective protection against Mastitis by cows
  • Used in the general dairy hygiene
  • The typical concentration of Chlorhexidine Gluconate as an antiseptic is 0,5 – 4%.


Regulatory Status

API (Ph. Eur.)

  • EU-GMP (Good Manufacturing Practice)
  • CEP
  • DMF (Drug Master File) issued 2006 No. 21946


Biocide (BPR)

RN Laboratories have been included under Article 95 of the BPR through a letter of access to the substance dossier from Evonik for the three product types:

  • Product type 1: Human hygiene biocidal products
  • Product type 2: Private area and health care disinfectants
  • Product type 3: Veterinary hygiene biocidal products


REACh registration no. 01-2119946568-22-0005

 

Cosmetic

Chlorhexidine Gluconate is registered in the CosIng (Cosmetic Ingredient Database). This means that it can be used in cosmetics as a preservative with a maximum concentration of 0.3%.

 

Packaging

  • IBC’s of 1000 kg, drums of 200 kg and 50 kg

     

Chlorhexidine HCl

Chlorhexidine HCL is a high quality antispetic, disinfectant and preservative used for a broad field of indications. 

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