MedPath

Benzyl alcohol

Generic Name
Benzyl alcohol
Brand Names
Cipro, Cipro HC, Itch-X, Ivy-dry Cream, Ulesfia, Zilactin Cold Sore
Drug Type
Small Molecule
Chemical Formula
C7H8O
CAS Number
100-51-6
Unique Ingredient Identifier
LKG8494WBH

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
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
SALONPAS PAIN RELIEVING SOLUTION
hisamitsu america, inc.
02511428
Solution - Topical
10 % / W/W
12/14/2022
THOMAS FORMULA NO 47
thomas hair and scalp specialists
00289469
Liquid - Topical
1.07 %
12/31/1974
SALONPAS PAIN RELIEVING CREAM
hisamitsu america, inc.
02511339
Cream - Topical
10 % / W/W
6/2/2022
THOMAS OXYBORNIOL
thomas hair and scalp specialists
00289353
Liquid - Topical
0.041 %
12/31/1974
THOMAS FORMULA NO 96
thomas hair and scalp specialists
00289426
Liquid - Topical
.44 %
12/31/1974
THOMAS FORMULA NO 28
thomas hair and scalp specialists
00289426
Liquid - Topical
.4386 %
12/31/1974
ITCH-X GEL
b.f. ascher & company inc.
02186918
Gel - Topical
10 %
12/31/1994
DENTURE ORAJEL GEL
commerce pharmaceutics inc.
01967908
Gel - Topical ,  Buccal
1 %
12/17/1997
BABY'S OWN TEETHING GEL 2.5%
dannorth laboratories inc.
02021773
Gel - Topical
2.5 %
12/31/1990
BABY'S OWN TEETHING GEL - 2.5%
block drug company (canada) ltd.
02227533
Gel - Topical
2.5 %
3/2/1998

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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