Medicine
Betasept 0.04 mg/mL topical solution
Betasept 0.04 mg/mL topical solution is a prescription medicine containing Chlorhexidine for topical use, marketed by Xttrium Laboratories, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Other information store at 20-25°C (68-77°F) avoid excessive heat above 40°C…
Key facts
- Active ingredient (INN)
- Chlorhexidine
- Brand
- Betasept
- Strength
- 0.04 mg/mL
- Dosage form
- Topical solution
- Route
- Topical
- Packs
- 3785 mL, 118 mL, 237 mL and 3 more
- Marketing authorisation holder
- Xttrium Laboratories
- Manufacturer
- Xttrium Laboratories
- Origin register
- US FDA, United States
- Storage
- Other information store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A01AB03 Chlorhexidine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 June 1993
- Identifiers
- RxCUI 211365, 834150DailyMed set ID 4a6451d7-b347-37ac-e054-00144ff8d46cNDC 0116-0200Application NDA019125
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 3785 mL in 1 bottle | 0116-0200-01 | Xttrium Laboratories | 1 June 1993 |
| 118 mL in 1 bottle | 0116-0200-04 | Xttrium Laboratories | 1 June 1993 |
| 237 mL in 1 bottle | 0116-0200-08 | Xttrium Laboratories | 1 June 1993 |
| 473 mL in 1 bottle | 0116-0200-16 | Xttrium Laboratories | 1 June 1993 |
| 946 mL in 1 bottle | 0116-0200-30 | Xttrium Laboratories | 1 June 1993 |
| 946 mL in 1 bottle | 0116-0200-32 | Xttrium Laboratories | 1 June 1993 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 17 September 1976 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Chlorhexidine
Clinical summary
Chlorhexidine is a prescription medicine. It is available as oral rinse, solution and oral liquid for dental and buccal use. MedsAcross supplies Chlorhexidine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about ChlorhexidineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ANTISEPTIC SKIN CLEANSER prescribing information (Xttrium Laboratories) · U.S. National Library of Medicine, DailyMed
Need Betasept 0.04 mg/mL topical solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.