Overview
No overview information available.
Indication
Ulesfia (benzyl alcohol) lotion is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. Ulesfia Lotion does not have ovicidal activity.
Associated Conditions
- Cold Sore
- Fever blister
- Head Lice Infestation
- Insect Bites
- Oral Pain
- Skin Irritation
- Sunburn
- Abrasions
- Minor burns
- Superficial Wounds
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/07/08 | N/A | Completed | Kahramanmaras Sutcu Imam University | ||
2015/12/09 | Phase 3 | Completed | |||
2015/09/21 | N/A | Completed | |||
2012/09/21 | N/A | Completed | |||
2010/07/23 | Phase 1 | Completed | |||
2009/09/21 | Phase 3 | Completed | |||
2008/05/13 | Phase 4 | Completed | |||
2008/04/28 | Phase 3 | Completed | |||
2008/04/01 | Phase 1 | Completed | |||
2008/04/01 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Stat Rx USA | 16590-053 | AURICULAR (OTIC) | 9 mg in 1 mL | 10/27/2009 | |
| Physicians Total Care, Inc. | 54868-4365 | AURICULAR (OTIC) | 9 mg in 1 mL | 12/13/2010 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Benzyl Alcohol Injection | 国药准字H36021623 | 化学药品 | 注射剂 | 7/17/2022 | |
| Benzyl Alcohol Injection | 国药准字H51022493 | 化学药品 | 注射剂(注射液) | 6/23/2021 | |
| Benzyl Alcohol Injection | 国药准字H50021015 | 化学药品 | 注射剂 | 8/3/2020 | |
| Benzyl Alcohol Injection | 国药准字H51021973 | 化学药品 | 注射剂(注射液) | 1/28/2021 | |
| Benzyl Alcohol Injection | 国药准字H50021017 | 化学药品 | 注射剂 | 8/3/2020 | |
| Benzyl Alcohol Injection | 国药准字H20064262 | 化学药品 | 注射剂 | 12/21/2020 | |
| Benzyl Alcohol Injection | 国药准字H14022650 | 化学药品 | 注射剂 | 3/9/2020 | |
| Benzyl Alcohol Injection | 国药准字H36021982 | 化学药品 | 注射剂 | 7/17/2022 | |
| Benzyl Alcohol Injection | 国药准字H32024869 | 化学药品 | 注射剂 | 6/15/2020 | |
| Benzyl Alcohol Injection | 国药准字H32024741 | 化学药品 | 注射剂 | 10/10/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BIOCOL MEDICATED THROAT LOZENGE orange | 42956 | Medicine | A | 4/2/1993 | |
| BIOCOL MEDICATED THROAT LOZENGES | 34750 | Medicine | A | 2/27/1992 | |
| CEPACOL ORANGE CITRUS ANTIBACTERIAL THROAT LOZENGES | 76287 | Medicine | A | 10/31/2000 | |
| CODRAL SORE THROAT LOZENGES menthol flavour lozenge blister pack | 228448 | Medicine | A | 9/26/2014 | |
| Cepacol Antibacterial Throat Lozenges Menthol and Eucalyptus Flavour | 10100 | Medicine | A | 7/8/1991 | |
| CEPACOL ANTIBACTERIAL THROAT LOZENGES honey & lemon flavour blister pack | 52421 | Medicine | A | 5/17/1995 | |
| CODRAL SORE THROAT LOZENGES honey and lemon flavour lozenge blister pack | 212156 | Medicine | A | 7/11/2013 | |
| BIOCOL MEDICATED THROAT LOZENGE - BLACKCURRANT | 42955 | Medicine | A | 4/2/1993 |
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