MYCOZYL AP- miconazole nitrate powder 
PureTek Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Mycozyl AP

Active ingredient

Miconazole Nitrate 2.0%

Purpose

Antifungal

Uses

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

Label

MYCOZYL AP 
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-442
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 85 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-442-0785 g in 1 BOTTLE; Type 0: Not a Combination Product12/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/08/2020
Labeler - PureTek Corporation (785961046)
Establishment
NameAddressID/FEIBusiness Operations
PureTek Corporation785961046manufacture(59088-442) , label(59088-442)

Revised: 1/2023
Document Id: f204ed3a-fde8-ab55-e053-2995a90aa29f
Set id: b3c46a30-7ff2-0dc4-e053-2995a90aa571
Version: 4
Effective Time: 20230111
 
PureTek Corporation