SILKA ANTIFUNGAL FOOT- miconazole nitrate powder

Silka Antifungal Foot by

Drug Labeling and Warnings

Silka Antifungal Foot by is a Otc medication manufactured, distributed, or labeled by Genomma Lab, CGI Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SILKA ANTIFUNGAL FOOT 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-028
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: 50066-028-03	85 g in 1 BOTTLE; Type 0: Not a Combination Product	08/09/2018

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

Labeler - Genomma Lab (832323534)

Registrant - CGI Packaging, LLC (080691099)

Establishment
Name	Address	ID/FEI	Business Operations
CGI Packaging, LLC		080691099	manufacture(50066-028)