Miconatate™

Miconatate™
SPL v3
SPL
SPL Set ID c45c8f8f-9042-a428-e053-2a95a90acda9
Route
TOPICAL
Published
Effective Date 2021-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (0.3 g) Miconazole (2 g)
Inactive Ingredients
Tea Tree Oil Glycerin Apple Cider Vinegar Laureth-4 Benzyl Alcohol .alpha.-tocopherol Acetate, Dl- Dimethyl Sulfoxide Eucalyptus Oil Lavender Oil Polyethylene Glycol 400 Argan Oil Levomenol Carthamus Tinctorius (safflower) Oleosomes Sodium Benzoate Ginger Cananga Odorata Flower Xylitol Silicon Dioxide Aloe Vera Leaf Nylon-12 Starch, Corn Kukui Nut Oil Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-02

Description

Miconazole Nitrate 2%

Purpose

Antifungal

How Supplied

Mycozyl AL™ Antifungal Liquid is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush applicator (NDC 59088-443-03)


Medication Information

Purpose

Antifungal

How Supplied

Mycozyl AL™ Antifungal Liquid is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush applicator (NDC 59088-443-03)

Description

Miconazole Nitrate 2%

Uses
  • for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis).
  • relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions.
Warnings

For external use only.

Directions
  • clean 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
  • 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 condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
Do Not Use On
  • children under 2 years of age unless directed by a doctor
Miconatate™

Packaged in the USA by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Active Ingredient

Miconazole Nitrate 2%

Other Information
  • protect from freezing
  • avoid excessive heat
  • do not use if package is damaged
Inactive Ingredients

Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Bisabolol, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance, Nylon-12, Silica, Sodium Benzoate, Sodium Hyaluronate, Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract.

When Using This Product
  • do not get into eyes
Stop Use and Ask A Doctor
  • for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks
  • for prevention of athlete’s foot - if irritation occurs, discontinue use and consult a doctor
Stop Use and Ask A Doctor If
  • for athlete's foot and ringworm - irritation occurs or there is no improvement within 4 weeks
  • for jock itch - irritation occurs or there is no improvement within 2 weeks
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 treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis).
  • relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions.
Purpose

Antifungal

Warnings

For external use only.

Directions
  • clean 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
  • 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 condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
How Supplied

Mycozyl AL™ Antifungal Liquid is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush applicator (NDC 59088-443-03)

Do Not Use On (Do not use on)
  • children under 2 years of age unless directed by a doctor
Miconatate™

Packaged in the USA by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Active Ingredient (Active ingredient)

Miconazole Nitrate 2%

Other Information (Other information)
  • protect from freezing
  • avoid excessive heat
  • do not use if package is damaged
Inactive Ingredients (Inactive ingredients)

Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Bisabolol, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance, Nylon-12, Silica, Sodium Benzoate, Sodium Hyaluronate, Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract.

When Using This Product (When using this product)
  • do not get into eyes
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks
  • for prevention of athlete’s foot - if irritation occurs, discontinue use and consult a doctor
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • for athlete's foot and ringworm - irritation occurs or there is no improvement within 4 weeks
  • for jock itch - irritation occurs or there is no improvement within 2 weeks
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.


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