Label: MICONATATE- miconazole nitrate and tolnaftate kit
- NDC Code(s): 59088-442-07, 59088-443-03, 59088-778-00
- Packager: PureTek Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 11, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Mycozyl AP
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use on
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
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
- Inactive ingredients
- Mycozylal AL
- Active ingredient
- Purpose
-
Uses
- for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).
- relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions.
- for the prevention of most Athlete’s foot with daily use.
- eliminates fungus on fingers, toes, and around the nails.
- eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.
- Warnings
- Do not use on
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
-
Directions
- clean the affected area and dry thoroughly
- apply a thin layer of the product over affected area twice daily (morning and night) paying special attention to the edges of the nail, cuticles, and skin around the nails 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
- if condition persists longer, consult a doctor.
Use under the direction of a medical practitioner
- Other information
- How Supplied
- Inactive ingredients
- Miconatate™
-
INGREDIENTS AND APPEARANCE
MICONATATE
miconazole nitrate and tolnaftate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-778 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59088-778-00 1 in 1 CARTON; Type 0: Not a Combination Product 09/02/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 0 BOTTLE, WITH APPLICATOR 1 mL in 30 Part 2 0 BOTTLE 1 g in 85 Part 1 of 2 MYCOZYL AL
tolnaftate liquidProduct Information Item Code (Source) NDC:59088-443 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 0.3 g in 30 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:59088-443-03 30 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 06/09/2021 Part 2 of 2 MYCOZYL AP
miconazole nitrate powderProduct Information 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) 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 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 12/08/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 09/02/2021 Labeler - PureTek Corporation (785961046)