ATHLET FOOT WELL AT WALGREENS- miconazole nitrate powder 
Walgreens

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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Drug Facts

Ative ingredients                      Purpose

Miconazole Nitrate                    Antifungal

Use for the cure of most athlete’s foot

Warnings
For external use only

Avoid contact with eyes
Do not use on children under 2 years of age unless directed by a doctor
Stop use and ask a doctor if irritation occurs or there is no improvement within 4 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 the affected area twice daily
(morning and night) or as directed by a doctor.
• Supervise children in the use of this product.
• Pay special attention to spaces between the toes; wear well-fitting,
ventilated shoes and change shoes and socks at least once daily.
• Use daily for 4 weeks.
• If condition persists longer, consult a doctor.
• This product is not effective on the scalp or nails.

Inactive ingredients Aldioxa, Cellulose, Chloroxylenol, Fragrance, Imidazolidinyl Urea, Talc

image description

ATHLET FOOT  WELL AT WALGREENS
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) Miconazole Nitrate2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Talc (UNII: 7SEV7J4R1U)  
ALUMINUM ACETYLSALICYLATE (UNII: ED7L5F608H)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
Chloroxylenol (UNII: 0F32U78V2Q)  
IMIDUREA (UNII: M629807ATL)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-9001-2574 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/201503/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/15/201503/08/2018
Labeler - Walgreens (008965063)
Registrant - Product Quest (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Ei Inc105803274manufacture(0363-9001) , label(0363-9001)

Revised: 3/2018
 
Walgreens