Label: ATHLETES FOOT- terbinafine hydrochloride cream

  • NDC Code(s): 11822-0080-1, 11822-0080-2
  • Packager: Rite Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 29, 2024

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  • SPL UNCLASSIFIED SECTION

    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 productdo not get into the eyes. If eye contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor iftoo 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 footwear 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 weekor as directed by a doctor
        • on the bottom or sides of the foot:apply twice a day (morning and night) for 2 weeksor as directed by a doctor
      • for jock itch and ringworm:apply once a day (morning ornight) for 1 weekor as directed by a doctor
      • wash hands after each use
    • children under 12 years: ask a doctor

    Figure
  • 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

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    RITE AID, 30 HUNTER LANE,
    CAMP HILL, PA 17011

  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

    terbinafine-01Athlete's Foot Cream

    Terbinafine Hydrochloride Cream 1%

    ANTIFUNGAL

    RITE
    AID ®
    PHARMACY

    NET WT 0.5 OZ (15 g)

  • INGREDIENTS AND APPEARANCE
    ATHLETES FOOT 
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0080
    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)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0080-11 in 1 CARTON10/28/2019
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11822-0080-21 in 1 CARTON10/28/2019
    230 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07751107/02/2007
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295manufacture(11822-0080)
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