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Terbinafine Hydrochloride by REMEDYREPACK INC.

Medically reviewed on May 25, 2017

Dosage form: cream
Ingredients: TERBINAFINE HYDROCHLORIDE 1g in 100g
Labeler: REMEDYREPACK INC.
NDC Code: 70518-0553

Terbinafine Hydrochloride

Cream 1%

Antifungal Cream

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 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.
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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

2 weeks on the bottom or sides of the foot

Other information
  • do not use if seal on tube is broken or is not visible
  • store at controlled room temperature 20°-25°C (68°-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.

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

DRUG: Terbinafine Hydrochloride

GENERIC: Terbinafine Hydrochloride

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 70518-0553-0

COLOR: white

PACKAGING: 30 g in 1 TUBE

ACTIVE INGREDIENT(S):

  • Terbinafine Hydrochloride 1g in 100g

INACTIVE INGREDIENT(S):

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

TERBINAFINE HYDROCHLORIDE 
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0553(NDC:51672-2080)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TERBINAFINE HYDROCHLORIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CETYL ALCOHOL 
CETYL PALMITATE 
ISOPROPYL MYRISTATE 
POLYSORBATE 60 
WATER 
SODIUM HYDROXIDE 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70518-0553-030 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751105/25/2017
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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