Drug Labeling and Warnings

Drug Details [pdf]

SILKA ANTIFUNGAL FOOT- miconazole nitrate powder 
Genomma Lab

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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Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

For the cure of most athlete's foot.

Warnings

For external use only.

Do not use on children of 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes.

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, seek 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 space between the toes; wear well-fitting, ventilated shoes and change socks at least once daily.
• Use daily for 4 weeks.
• If condition persists longer, consult a doctor.
• This product is not effective on scalp and nails.

Inactive Ingredients

Aldioxa, Cellulose, Chloroxylenol, Fragrance, Imidazolidynl Urea, Talc.

SILKA ANTIFUNGAL FOOT 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-277
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
ALPHA CELLULOSE (UNII: I355QGZ19A)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
IMIDUREA (UNII: M629807ATL)
TALC (UNII: 7SEV7J4R1U)
ALDIOXA (UNII: 8T66I31YNK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-277-03	85 g in 1 BOTTLE; Type 0: Not a Combination Product	08/09/2018	02/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/09/2018	02/03/2020

Labeler - Genomma Lab (832323534)

Registrant - Derma Care Research Labs (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research labs		116817470	manufacture(50066-277)

Revised: 10/2022

Document Id: eb7c54e8-fbce-7bcd-e053-2a95a90a57d0

34390-5

Set id: 828026cc-ea65-7b3d-e053-2a91aa0a7588

Version: 2

Effective Time: 20221020