FDA Label for Macerrx Web

View Indications, Usage & Precautions

Macerrx Web Product Label

The following document was submitted to the FDA by the labeler of this product Clinical Therapeutic Solutions. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient:



-Miconazole Nitrate 2.00%


Purpose



Antifungal


Uses:



Proven clinically to cure most:

  • athlete’s foot (tinea pedis)
  • ringworm (tinea corporis) Effectively soothese and relieves:
  • itching
  • burning
  • cracking
  • Helps prevent most athlete’s foot from coming back with daily use
  • For the treatment of superficial skin infections caused by yeast (Candida albicans, intertrigo) and erythrasma

Warnings:



  • For external use only

When Using This Product:



  • Avoid contact with eyes

Stop Use And Ask A Doctor If:



  • Irritation occurs
  • There is no improvement within 4 weeks

Keep Out Of Reach Of Children.



If swallowed, contact physician or poison control center immediately.


Store At Room



temperature 68-77°F (20-25° C)


Directions:



  • clean the affected area and dry thoroughly
  • apply a thin layer over the affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete’s foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • use daily for 4 weeks. If condition lasts longer, ask a doctor
  • to prevent athlete’s foot, apply to the feet once or twice daily
  • this product is not effective on the scalp or nails

Other Ingredients:



Acetic Acid, Aqua (Deionized Water), Carbomer, Ethylhexylglycerin, Hydroxyethylcellulose, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, SD-Alcohol, Triethanolamine


Macerrxtm Web Gel



Distributed by:
CTS CLINICAL THERAPEUTIC SOLUTIONS
A Part of bako's Integrated Physician Solutions

PO Box 1257, Wall, NJ 07719
732.894.9450 • www.BakoCTS.com

PROFESSIONAL

c 2013 Clinical Therapeutic Solutions


Package Label.Principal Display Panel



MacerRxTM Web Gel

Miconazole Nitrate 2%
In an Astringent Vehicle

FAST DRYING
DESIGNED FOR WEB SPACES
PROPRIETARY FORMULA

Dispensed Only by Physicians

CTS CLINICAL THERAPEUTIC SOLUTIONS
A Part of bako's Integrated Physician Solutions

NET WT. 2.0 oz (56 g)

PROFESSIONAL


Macerrx Web Gel 2Oz/56G (44577-205-56)




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