Mycozyl Ap

Mycozyl Ap
SPL v5
SPL
SPL Set ID b3c46a30-7ff2-0dc4-e053-2995a90aa571
Route
TOPICAL
Published
Effective Date 2020-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Levomenol Silicon Dioxide Sodium Benzoate Hyaluronate Sodium Starch, Corn Ginger Aloe Vera Leaf Nylon-12 Carthamus Tinctorius (safflower) Oleosomes Kukui Nut Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-08

Description

Miconazole Nitrate 2.0%

Purpose

Antifungal


Medication Information

Warnings and Precautions

For external use only.

Purpose

Antifungal

Description

Miconazole Nitrate 2.0%

Uses
  • for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
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

Active Ingredient

Miconazole Nitrate 2.0%

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
Mycozyl Antifungal Powder

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, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
Warnings and Precautions (34071-1)

For external use only.

Purpose

Antifungal

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 (Do not use on)

■ children under 2 years of age unless directed by a doctor

Active Ingredient (Active ingredient)

Miconazole Nitrate 2.0%

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
Mycozyl Antifungal Powder

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.


Advanced Ingredient Data


Raw Label Data

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