ANTIFUNGAL FOOT- terbinafine hydrochloride cream 
American Sales Company

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Antifungal Foot 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 the eyes
  • for vaginal yeast infections

When using this product do not get into the 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 older
    • 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
1 week between the toes
Figure
2 weeks on the bottom or sides of the foot
Figure

Other information

Inactive ingredients

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

Questions?

Call 1-866-923-4914

DISTRIBUTED
BY: FOODHOLD
U.S.A., LLC
LANDOVER, MD
20785

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

NDC 41520-080-02

Compare to the
active ingredient
in Lamisil AT®*

CAREone®

Antifungal Cream
Terbinafine Hydrochloride Cream 1% • Antifungal

Full Prescription Strength

OUR PHARMACISTS
RECOMMEND
Rx

NET WT 1 OZ (30 g)

Cures Most Athlete's Foot •
Relieves Itching & Burning •

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
ANTIFUNGAL FOOT 
terbinafine hydrochloride cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-080
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine Hydrochloride 1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
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
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-080-02 1 in 1 CARTON 07/02/2007
1 30 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077511 07/02/2007
Labeler - American Sales Company (809183973)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(41520-080)

Revised: 4/2019
Document Id: 23325692-c7be-4e4b-b7ea-09d5fe8578f0
Set id: 3da3a963-b5c5-4195-9feb-7dc51a7321c9
Version: 2
Effective Time: 20190410
 
American Sales Company