MICONATATE- miconazole nitrate and tolnaftate 
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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Miconatate™

Kit
Mycozyl AP™, Miconazole Nitrate 2%, Antifungal Powder (3 oz / 85 g)
Mycozyl AL™, Tolnaftate 1%, Antifungal Liquid (1 fl oz / 30 mL)

Mycozyl AP

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

Warnings

For external use only.

Do not use on

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

Other information

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.

Mycozylal AL

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use on

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

When using this product

Stop use and ask a doctor

Keep out of reach of children.

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

Directions

Use under the direction of a medical practitioner

Other information

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)

Inactive ingredients

Apple Cider Vinegar, Argania Spinosa (Argan) Kernel Oil, Benzyl Alcohol, DMSO (Dimethyl Sulfoxide), Eucalyptus Globulus (Eucalyptus) Leaf Oil, Glycerin, Laureth-4, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-8, DL-alpha-tocopheryl acetate.

Miconatate™

Packaged in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873

Label

MICONATATE 
miconazole nitrate and tolnaftate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-778
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-778-001 in 1 CARTON; Type 0: Not a Combination Product09/02/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 10 BOTTLE, WITH APPLICATOR 1 mL  in 30 
Part 20 BOTTLE 1 g  in 85 
Part 1 of 2
MYCOZYL AL 
tolnaftate liquid
Product Information
Item Code (Source)NDC:59088-443
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE0.3 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
GLYCERIN (UNII: PDC6A3C0OX)  
APPLE CIDER VINEGAR (UNII: 0UE22Q87VC)  
LAURETH-4 (UNII: 6HQ855798J)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
ARGAN OIL (UNII: 4V59G5UW9X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-443-0330 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/09/2021
Part 2 of 2
MYCOZYL AP 
miconazole nitrate powder
Product Information
Item 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)  
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GINGER (UNII: C5529G5JPQ)  
CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)  
XYLITOL (UNII: VCQ006KQ1E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
NYLON-12 (UNII: 446U8J075B)  
STARCH, CORN (UNII: O8232NY3SJ)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-442-0785 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/02/2021
Labeler - PureTek Corporation (785961046)

Revised: 1/2023
Document Id: f2054cd2-838e-7f92-e053-2995a90a9acc
Set id: c45c8f8f-9042-a428-e053-2a95a90acda9
Version: 2
Effective Time: 20230111
 
PureTek Corporation