Macerrx Web Cream
FDA Label NDC 44577-205

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Clinical Therapeutic Solutions for the product Macerrx Web (NDC 44577-205). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient:, purpose, uses:, warnings:, when using this product:, stop use and ask a doctor if:, keep out of reach of children., store at room, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Outer Label (Outerlabel)

Outer Label (Outerlabel)

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