Premier Solutions Miconazoleaf Powder - Talc Free

Premier Solutions Miconazoleaf Powder - Talc Free
SPL v7
SPL
SPL Set ID f186bdc1-db6c-0fab-e053-2995a90a7c58
Route
TOPICAL
Published
Effective Date 2022-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (1.42 g)
Inactive Ingredients
Allantoin Chloroxylenol Imidurea Microcrystalline Cellulose Tricalcium Phosphate Zea Mays Subsp. Mays Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-04-11 Until 2027-01-31

Description

Miconazole nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole nitrate 2%

Uses

for the cure of most athlete's foot, jock itch and ringworm

Warnings

For external use only.

Directions
  • clean the affected area & dry thoroughly
  • apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if conditions persist longer, consult a doctor
  • this product is not effective on the scalp or nails
Do Not Use

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

Questions?

call 1-866-964-0939

Active Ingredient

Miconazole nitrate 2%

Other Information
  • store between 59º - 86ºF
  • lightly shake bottle to loosen settled powder
Inactive Ingredient

allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate, zea mays (corn) starch

Principal Display Panel

CORE VALUES

Absorbs Moisture

Miconazorb AF

ANTI-FUNGAL POWDER

Miconazole Nitrate 2%

Cures Most:

  • Athlete's foot
  • Jock itch
  • Ringworm

Relieves itching, burning, scaling and chafing

Talc-Free

NET WT 2.5 OZ (71 g)

When Using This Product

avoid contact with the eyes.

Stop and Ask A Doctor If

irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.

Keep Out of Reach of Children.

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


Structured Label Content

Uses

for the cure of most athlete's foot, jock itch and ringworm

Purpose

Antifungal

Warnings

For external use only.

Directions
  • clean the affected area & dry thoroughly
  • apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if conditions persist longer, consult a doctor
  • this product is not effective on the scalp or nails
Do Not Use (Do not use)

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

Questions?

call 1-866-964-0939

Active Ingredient (Active ingredient)

Miconazole nitrate 2%

Other Information (Other information)
  • store between 59º - 86ºF
  • lightly shake bottle to loosen settled powder
Inactive Ingredient (Inactive ingredient)

allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate, zea mays (corn) starch

Principal Display Panel

CORE VALUES

Absorbs Moisture

Miconazorb AF

ANTI-FUNGAL POWDER

Miconazole Nitrate 2%

Cures Most:

  • Athlete's foot
  • Jock itch
  • Ringworm

Relieves itching, burning, scaling and chafing

Talc-Free

NET WT 2.5 OZ (71 g)

When Using This Product (When using this product)

avoid contact with the eyes.

Stop and Ask A Doctor If (Stop and ask a doctor if)

irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.

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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