FDA — authorised 23 May 1980
- Application: NDA018300
- Marketing authorisation holder: MOLNLYCKE HLTH
- Local brand name: HIBISTAT
- Indication: SOLUTION — TOPICAL
- Status: approved
🇺🇸 70% alcohol - 0.5% clorhexidine in United States
FDA authorised 70% alcohol - 0.5% clorhexidine on 23 May 1980
Marketing authorisations
FDA — authorised 24 December 1984
- Application: NDA019125
- Marketing authorisation holder: XTTRIUM
- Local brand name: DYNA-HEX 4
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 17 December 1985
- Application: NDA019422
- Marketing authorisation holder: XTTRIUM
- Local brand name: DYNA-HEX 2
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 24 July 1986
- Application: ANDA070104
- Marketing authorisation holder: MATRIX MEDCL
- Local brand name: STERI-STAT
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 17 December 1987
- Application: ANDA071419
- Marketing authorisation holder: SOAPCO
- Local brand name: BRIAN CARE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 2 December 1988
- Application: NDA019793
- Marketing authorisation holder: CAREFUSION 2200
- Local brand name: PHARMASEAL SCRUB CARE
- Indication: SPONGE — TOPICAL
- Status: approved
FDA — authorised 31 March 1989
- Application: NDA019822
- Marketing authorisation holder: GRIFFEN
- Local brand name: BIOSCRUB
- Indication: SPONGE — TOPICAL
- Status: approved
FDA — authorised 24 October 1989
- Application: ANDA072525
- Marketing authorisation holder: BECTON DICKINSON
- Local brand name: CHLORHEXIDINE GLUCONATE
- Indication: SPONGE — TOPICAL
- Status: approved
FDA — authorised 28 January 1992
- Application: ANDA072292
- Marketing authorisation holder: J AND J
- Local brand name: PREVACARE R
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 15 December 1995
- Application: ANDA074522
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: CHLORHEXIDINE GLUCONATE
- Indication: SOLUTION — DENTAL
- Status: approved
FDA — authorised 28 December 1995
- Application: ANDA074291
- Marketing authorisation holder: LYNE
- Local brand name: CHLORHEXIDINE GLUCONATE
- Indication: SOLUTION — DENTAL
- Status: approved
FDA — authorised 7 May 1996
- Application: ANDA074356
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: CHLORHEXIDINE GLUCONATE
- Indication: SOLUTION — DENTAL
- Status: approved
FDA — authorised 11 September 1997
- Application: NDA020111
- Marketing authorisation holder: BAJAJ
- Local brand name: CHLORHEXIDINE GLUCONATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 14 March 2000
- Application: ANDA073416
- Marketing authorisation holder: BECTON DICKINSON
- Local brand name: E-Z SCRUB
- Indication: SPONGE — TOPICAL
- Status: approved
FDA — authorised 14 July 2000
- Application: NDA020832
- Marketing authorisation holder: BECTON DICKINSON CO
- Local brand name: CHLORAPREP ONE-STEP FREPP
- Indication: SPONGE — TOPICAL
- Status: approved
FDA — authorised 14 November 2000
- Application: ANDA075561
- Marketing authorisation holder: BAJAJ
- Local brand name: CHLORHEXIDINE GLUCONATE
- Indication: SOLUTION — DENTAL
- Status: approved
FDA — authorised 7 October 2002
- Application: NDA021555
- Marketing authorisation holder: BECTON DICKINSON CO
- Local brand name: CHLORAPREP SINGLE SWABSTICK
- Indication: SWAB — TOPICAL
- Status: approved
FDA — authorised 3 March 2004
- Application: ANDA075006
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CHLORHEXIDINE GLUCONATE
- Indication: SOLUTION — DENTAL
- Status: approved
FDA — authorised 3 June 2005
- Application: NDA021524
- Marketing authorisation holder: PROF DSPLS
- Local brand name: PREVANTICS SWAB
- Indication: SWAB — TOPICAL
- Status: approved
FDA — authorised 18 June 2009
- Application: ANDA077789
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CHLORHEXIDINE GLUCONATE
- Indication: SOLUTION — DENTAL
- Status: approved
FDA — authorised 8 August 2018
- Application: NDA208288
- Marketing authorisation holder: SOLVENTUM
- Local brand name: SOLUPREP S
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 20 November 2018
- Application: NDA207964
- Marketing authorisation holder: MEDLINE INDUSTRIES
- Local brand name: READYPREP CHG
- Indication: CLOTH — TOPICAL
- Status: approved
FDA
- Application: NDA019490
- Marketing authorisation holder: KENDALL IL
- Local brand name: CHLORHEXIDINE GLUCONATE
- Indication: SPONGE — TOPICAL
- Status: approved
FDA
- Status: approved
70% alcohol - 0.5% clorhexidine in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is 70% alcohol - 0.5% clorhexidine approved in United States?
Yes. FDA authorised it on 23 May 1980; FDA authorised it on 24 December 1984; FDA authorised it on 17 December 1985.
Who is the marketing authorisation holder for 70% alcohol - 0.5% clorhexidine in United States?
MOLNLYCKE HLTH holds the US marketing authorisation.