Label: ATHLETES FOOT- miconazole nitrate spray
- NDC Code(s): 0363-0557-90
- Packager: Walgreen Company
- 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.
Updated September 10, 2020
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- Active ingredient
For external use only
Flammable: Do not use while smoking or near heat or flame
When using this product
- avoid contact with the eyes
- use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
- contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F (49°C).
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch)
- wash affected area and dry thoroughly
- shake can well and spray a thin layer over affected area twice daily (morning and night)
- 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, ask a doctor
- this product is not effective on the scalp or nails
- in case of clogging, clean nozzle with a pin
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
INGREDIENTS AND APPEARANCE
miconazole nitrate spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0557 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 100 g Inactive Ingredients Ingredient Name Strength ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) ISOBUTANE (UNII: BXR49TP611) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TALC (UNII: 7SEV7J4R1U) ALCOHOL (UNII: 3K9958V90M) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) Product Characteristics Color WHITE (to off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0557-90 130 g in 1 CAN; Type 0: Not a Combination Product 06/09/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 06/09/2005 Labeler - Walgreen Company (008965063)