SILKA GEL- terbinafine hydrochloride gel 
All Natural Dynamics

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Silka ®

Gel

Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

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

Other information

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:51769-121
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:51769-121-3030 g in 1 TUBE; Type 0: Not a Combination Product01/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751101/18/2021
Labeler - All Natural Dynamics (962732892)
Registrant - All Natural Dynamics (962732892)
Establishment
NameAddressID/FEIBusiness Operations
Gelpharma S.A. de C.V.812773665manufacture(51769-121)

Revised: 1/2021
Document Id: b9d1bef7-4b9d-f2c9-e053-2995a90ae9ac
Set id: b9d1bef7-4b9c-f2c9-e053-2995a90ae9ac
Version: 3
Effective Time: 20210126
 
All Natural Dynamics