Silka ®

Silka ®
SPL v2
SPL
SPL Set ID 326d8586-042f-44f8-8530-e46b7b777bc3
Route
TOPICAL
Published
Effective Date 2019-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Terbinafine (1 g)
Inactive Ingredients
Benzyl Alcohol Cetyl Alcohol Cetyl Palmitate Isopropyl Myristate Polysorbate 60 Water Sodium Hydroxide Sorbitan Monostearate Stearyl Alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2007-07-02

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • cures most jock itch (tinea cruris)
  • relieves itching, burning, cracking and scaling which accompany this condition
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor iftoo much irritation occurs or gets worse

Section 50567-7

When using this productdo not get into eyes. If eye contact occurs, rinse thoroughly with water.

Warnings

For external use only

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
    • apply once a day (morning ornight) for 1 weekor as directed by a doctor
    • wash hands after each use
  • children under 12 years: ask a doctor
Do Not Use
  • on nails or scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections
Questions?

call 1 877 99 GENOM (43666)

Active Ingredient

Terbinafine hydrochloride 1%

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

Principal Display Panel 15 G Tube Carton

SILKA ®

Terbinafine Hydrochloride Cream 1%

ANTIFUNGAL CREAM

FULL PRESCRIPTION

STRENGTH

JOCK ITCH

CURES MOST JOCK ITCH

NET WT 0.5 oz (15 g)


Structured Label Content

Uses
  • cures most jock itch (tinea cruris)
  • relieves itching, burning, cracking and scaling which accompany this condition
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor iftoo much irritation occurs or gets worse

Section 50567-7 (50567-7)

When using this productdo not get into eyes. If eye contact occurs, rinse thoroughly with water.

Purpose

Antifungal

Warnings

For external use only

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
    • apply once a day (morning ornight) for 1 weekor as directed by a doctor
    • wash hands after each use
  • children under 12 years: ask a doctor
Do Not Use (Do not use)
  • on nails or scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections
Questions?

call 1 877 99 GENOM (43666)

Active Ingredient (Active ingredient)

Terbinafine hydrochloride 1%

Other Information (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 (Inactive ingredients)

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol

Principal Display Panel 15 G Tube Carton (PRINCIPAL DISPLAY PANEL - 15 g Tube Carton)

SILKA ®

Terbinafine Hydrochloride Cream 1%

ANTIFUNGAL CREAM

FULL PRESCRIPTION

STRENGTH

JOCK ITCH

CURES MOST JOCK ITCH

NET WT 0.5 oz (15 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)