Macerrx Web Gel

Macerrx Web Gel
SPL v5
SPL
SPL Set ID c9327f41-10f1-41f3-855b-838c701d6767
Route
TOPICAL
Published
Effective Date 2023-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Acetic Acid Water Carbomer Homopolymer, Unspecified Type Ethylhexylglycerin Witch Hazel Hydroxyethyl Cellulose, Unspecified Tea Tree Oil Dimethyl Sulfone Phenoxyethanol Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-06-06

Description

-Miconazole Nitrate 2.00%


Medication Information

Description

-Miconazole Nitrate 2.00%

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

Section 55105-1

Antifungal

Warnings:
  • For external use only
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
Store At Room

temperature 68-77ºF (20-25º C)

Package Labeling:

Active Ingredient:

-Miconazole Nitrate 2.00%

Other Ingredients:

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

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.


Structured Label Content

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

Section 55105-1 (55105-1)

Antifungal

Warnings:
  • For external use only
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
Store At Room (Store at room)

temperature 68-77ºF (20-25º C)

Package Labeling:

Active Ingredient:

-Miconazole Nitrate 2.00%

Other Ingredients:

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

When Using This Product: (When using this product:)
  • Avoid contact with eyes
Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • Irritation occurs
  • There is no improvement within 4 weeks
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, contact physician or poison control center immediately.


Advanced Ingredient Data


Raw Label Data

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