Silka ® Gel

Silka by

Drug Labeling and Warnings

Silka by is a Otc medication manufactured, distributed, or labeled by PCGI Wholesale, Gelpharma S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SILKA GEL- terbinafine hydrochloride gel 
PCGI Wholesale

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Silka ®

Gel

Drug Facts

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

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

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

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)

Distributed by:
PCGI Wholesale Chula Vista, CA, 91911

PRINCIPAL DISPLAY PANEL - 30g Tube Carton

Silka Gel

SILKA  GEL
terbinafine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73467-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE HYDROCHLORIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73467-121-3030 g in 1 TUBE; Type 0: Not a Combination Product01/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751101/18/202102/04/2021
Labeler - PCGI Wholesale (049983678)
Registrant - PCGI Wholesale (049983678)
Establishment
NameAddressID/FEIBusiness Operations
Gelpharma S.A. de C.V.812773665manufacture(73467-121)

Revised: 2/2021
 

Trademark Results [Silka]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SILKA
SILKA
90324381 not registered Live/Pending
silka kirtasiye imalat san. ve tic. ltd. sti
2020-11-17
SILKA
SILKA
86579232 not registered Live/Pending
2545-2509 QUEBEC INC.
2015-03-27
SILKA
SILKA
86012648 4545152 Live/Registered
Genomma Lab Internacional, S.A.B. de C.V.
2013-07-17
SILKA
SILKA
79277910 not registered Live/Pending
KARADENIZ PRES MOBILYA INSAAT VE OTOMOTIV SANAYI TICARET LIMITED SIRKETI
2019-11-04
SILKA
SILKA
75656499 not registered Dead/Abandoned
Meredith, Spencer B.
1999-03-09
SILKA
SILKA
73518707 1358301 Dead/Cancelled
SOCIETE DES PRODUITS NESTLE S.A.
1985-01-23

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