FDA Label for Silka Gel
View Indications, Usage & Precautions
Silka Gel Product Label
The following document was submitted to the FDA by the labeler of this product All Natural Dynamics. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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Drug Facts
Distributed by:
PCGI Wholesale Chula Vista, CA, 91911
Active Ingredient
Terbinafine hydrochloride 1%
Purpose
Antifungal
Uses
- cures most athletes foot (tinea pedis)
- cures most jock itch (tinea cruris) and ringworm (tinea corporis)
- relieves itching, burning, cracking and scaling which accompany this condition
Warnings
For external use only
Do Not Use
- on nails or scalp
- in or near the mouth or eyes
- for vaginal yeast infections
Otc - When Using
When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if too much irritation occurs or gets worse
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years and over:
- use the tip of the cap to break the seal and open the tube
- wash the affected skin with soap and water and dry completely before applying
- for athlete’s foot: wear well-fitting, ventilated shoes. Change shoes and socks at least once daily
- between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor.
- on bottom or sides of feet: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.
- for jock itch and ringworm: apply twice a day (morning and night) for 1 week or as directed by a doctor.
- wash hands after each use
- children under 12 years: ask a doctor
Other Information
- do not use if seal on tube is broken or is not visible
- store at controlled room temperature 20° to 25°C (68° to 77°F)
- see carton or tube crimp for lot number and expiration date
Inactive Ingredients
benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol
Questions?
call 1 877 99 GENOM (43666)
Principal Display Panel - 30G Tube Carton
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