TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride cream 
STRATEGIC SOURCING SERVICES LLC

----------

Terbinafine Hydrochloride Cream

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

  • 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 the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
    • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor
    • wash hands after each use
  • children under 12 years: ask a doctor
Image1 week between the toes
Image2 weeks on the bottom or sides of the foot

Other information

TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.

Inactive ingredients

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

Questions?

call 833-358-6431

Distributed by: McKesson Corp.,
via Strategic Sourcing Services LLC.
Memphis, TN 38141

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Foster & Thrive™

Athlete's Foot Cream

Terbinafine Hydrochloride Cream 1%
ANTIFUNGAL

NET WT 1 OZ (30 g)

Principal Display Panel - 30 g Tube Carton
TERBINAFINE HYDROCHLORIDE 
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine1 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)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70677-1003-11 in 1 CARTON06/30/2023
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751106/30/2023
Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(70677-1003)

Revised: 7/2023
Document Id: bc058e1f-e6b9-40d9-a65e-82a2df0d3fb7
Set id: 28a3ece3-78fb-4121-86a7-adc4a9d9540f
Version: 1
Effective Time: 20230705
 
STRATEGIC SOURCING SERVICES LLC