desenex

desenex
SPL v4
SPL
SPL Set ID 09964187-12f1-bbe6-e063-6394a90acba0
Route
topical
Published
Effective Date 2023-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
miconazole (20 mg)
Inactive Ingredients
starch, tapioca tricalcium phosphate caprylyl glycol water starch, corn 1,2-hexanediol aloe vera leaf yeast .beta.-d-glucan glycerin potassium sorbate sodium benzoate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-10-19

Purpose

Antifungal

Description

Miconazole nitrate 2%


Medication Information

Warnings

For external use only.

Avoid contact with eyes.

Uses
  • Cures most athlete’s foot (tinea pedis)
  • Relieves itching, burning, cracking, and discomfort
Purpose

Antifungal

Directions

Wash the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer,

consult a doctor. This product is not effective on the scalp or nails.

Other Information
  • store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].
Inactive Ingredients

1,2-Hexanediol, Aloe Barbadensis Leaf Juice Powder, Beta-Glucan, Caprylyl Glycol, Fragrance, Glycerin, Potassium Sorbate, Sodium Benzoate, Tapioca Starch, Tricalcium Phosphate, Water, Zea Mays (Corn) Starch

Description

Miconazole nitrate 2%

Questions?

call 1-833-279-6522

Do Not Use

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

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

Active Ingredient

Miconazole nitrate 2%

Principal Display

Desenex®

Antifungal Foot Powder

with 2% Miconazole Nitrate

PRESCRIPTION STRENGTH

Cures Most Athlete's Foot

Triple Action Powder

Relieves Itching, Burning, and Scaling

Attacks and Absorbs Moisture

All Day Odor Control

NET WT. 1.5 oz [43g]

PRODUCT PACKAGED BY WEIGHT NOT VOLUME

©2023 Crown Laboratories, Inc.

Distributed by: Crown Laboratories, Inc . Johnson City, TN 37604

DESENEX is a registered trademark of Crown Laboratories, Inc.

P12319.01

Keep Out of Reach of Children.

If swallowed, get medical help or contact a poison control center right away.


Structured Label Content

Warnings

For external use only.

Avoid contact with eyes.

Uses
  • Cures most athlete’s foot (tinea pedis)
  • Relieves itching, burning, cracking, and discomfort
Purpose

Antifungal

Directions

Wash the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer,

consult a doctor. This product is not effective on the scalp or nails.

Other Information (Other information)
  • store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].
Inactive Ingredients (Inactive ingredients)

1,2-Hexanediol, Aloe Barbadensis Leaf Juice Powder, Beta-Glucan, Caprylyl Glycol, Fragrance, Glycerin, Potassium Sorbate, Sodium Benzoate, Tapioca Starch, Tricalcium Phosphate, Water, Zea Mays (Corn) Starch

Questions?

call 1-833-279-6522

Do Not Use (Do not use)

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

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

Active Ingredient (Active ingredient)

Miconazole nitrate 2%

Principal Display

Desenex®

Antifungal Foot Powder

with 2% Miconazole Nitrate

PRESCRIPTION STRENGTH

Cures Most Athlete's Foot

Triple Action Powder

Relieves Itching, Burning, and Scaling

Attacks and Absorbs Moisture

All Day Odor Control

NET WT. 1.5 oz [43g]

PRODUCT PACKAGED BY WEIGHT NOT VOLUME

©2023 Crown Laboratories, Inc.

Distributed by: Crown Laboratories, Inc . Johnson City, TN 37604

DESENEX is a registered trademark of Crown Laboratories, Inc.

P12319.01

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a poison control center right away.


Advanced Ingredient Data


Raw Label Data

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