OTC Medication Information: Terbinafine Hydrochloride

TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride cream
A-S Medication Solutions

Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

  • cures most athlete’s foot (tinea pedis)
  • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany these conditions

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
Image 1 week between the toes Image 2 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.

  • 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 1-866-923-4914

Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

HOW SUPPLIED

Product: 50090-1278

NDC: 50090-1278-0 15 g in a TUBE / 1 in a CARTON

Terbinafine Hydrochloride

Label ImageLabel Image
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-1278(NDC:51672-2080)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TERBINAFINE HYDROCHLORIDE 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
benzyl alcohol
cetyl alcohol
cetyl palmitate
isopropyl myristate
polysorbate 60
water
sodium hydroxide
sorbitan monostearate
stearyl alcohol
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-1278-0 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (50090-1278-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077511 07/02/2007
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-1278)

Revised: 04/2021 A-S Medication Solutions

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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