Label: LAMISIL AT CREAM- terbinafine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 9, 2025

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  • Active Ingredient

    Terbinafine hydrochloride 1%

    Purpose

    Antifungal

  • Uses

    • cures most jock itch (tinea cruris)
    • 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
      • 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
  • Other Information

    • do no use if seal on tube is broken or is not visible
    • store at controlled room temperature 20-25°C (68-77°F)
  • Inactive Ingredients

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

  • Questions or comments?

    call 1-888-544-1880

  • 12 g Tube with Carton - For Jock Itch

    LAMISILAT
    CREAM
    TERBINAFINE HYDROCHLORIDE
    CREAM 1% - ANTIFUNGAL

    for JOCK ITCH

    ► CURES MOST JOCK ITCH
    ► FOR EFFECTIVE RELIEF OF ITCHING AND BURNING

    NET WT 12 g (0.42 oz)

    RECYCLABLE CARTON

    Distributed by: Karo Healthcare Inc.
    Morristown, NJ 07960 USA

    Made in Canada

    Trademarks owned or
    licensed by Karo Healthcare

    ©2024 Karo Healthcare
    or licensor.

    Karo
    healthcare

    Questions or
    comments?
    call 1-888-544-1880

    NDC
    84485-3607-1
    2004313_1

    Carton

    2004314_1

    Tube
  • INGREDIENTS AND APPEARANCE
    LAMISIL AT CREAM 
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84485-3607
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84485-3607-11 in 1 CARTON01/20/2025
    112 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02098001/20/2025
    Labeler - Karo Healthcare Inc. (119195452)
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