MYCOZYL AP- miconazole nitrate powder

Mycozyl AP by

Drug Labeling and Warnings

Mycozyl AP by is a Otc medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Miconazole Nitrate 2.0%

Purpose

Antifungal

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

For external use only.

Do not use on

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

When using this product

• do not get into eyes

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.

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.

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.

Mycozyl Antifungal Powder

INGREDIENTS AND APPEARANCE

MYCOZYL AP 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59088-442
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 85 g

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
STARCH, CORN (UNII: O8232NY3SJ)
GINGER (UNII: C5529G5JPQ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
NYLON-12 (UNII: 446U8J075B)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
KUKUI NUT OIL (UNII: TP11QR7B8R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-442-07	85 g in 1 BOTTLE; Type 0: Not a Combination Product	12/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	12/08/2020

Labeler - PureTek Corporation (785961046)

Establishment
Name	Address	ID/FEI	Business Operations
PureTek Corporation		785961046	manufacture(59088-442) , label(59088-442)