CLARUS AC ANTIFUNGAL SOLUTION- tolnaftate liquid 
Clinical Therapeutic Solutions

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CLARUS AC Antifungal Solution

Active ingredient

Tolnaftate 1%

Purpose

Topical Antifungal

Uses:

Warnings:

For external use only.

Do not use

  • on children under 2 years of age unless directed by a doctor.

When using this product

  • Avoid contact with the eyes.

Stop use and ask a doctor if

If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Other information:

Inactive ingredients:

N-Acetylcysteine, Beeswax, Dimethyl Isosorbite, Helianthus Annuus (Sunflower) Oil, Lactic Acid, Tocopheryl Acetate (Vitamin E), Undecylenic Acid, Urea.

Questions?

(M-F) (9am-5pm EST) 732-894-9450

Package Labeling:

Label

CLARUS AC ANTIFUNGAL SOLUTION 
tolnaftate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44577-128
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
LACTIC ACID (UNII: 33X04XA5AT)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
UNDECYLENIC ACID (UNII: K3D86KJ24N)  
UREA (UNII: 8W8T17847W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44577-128-0015 g in 1 TUBE; Type 0: Not a Combination Product03/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00503/01/2021
Labeler - Clinical Therapeutic Solutions (078402750)

Revised: 11/2023
Document Id: 09d7052e-ec64-ef60-e063-6294a90af214
Set id: 28ab9f1b-65cd-4405-a9a3-f3c9b836693d
Version: 2
Effective Time: 20231110
 
Clinical Therapeutic Solutions