Label: DR. LUKE WART REMOVER- wart remover liquid

  • NDC Code(s): 83176-013-01
  • Packager: Dr.luke Healthcare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 10, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Salicylic Acid 1%

    Chlorhexidine Acetate 1%

  • Purpose

    Wart Remover; Antiviral

  • Use

    For genital wart, and small size common wart, flat wart, filiform wart

  • Warnings

    ●For external use only.
    ●Children need to use it under adult supervision.
    ●Please tighten the cap immediately after using it
    ●Avoid contact with eyes, flush wtth water immediately if it gets into eyes.
    ●A small number of users may experience a slight burning or tingling sensation after use.
    ●Minor rash and swelling reactions may occur, needn't stop using.

  • Do not use

    If you are pregnant, breastfeeding
    If you are allergic to this product
    On children under 10 years
    On unhealed wounds after surgery

  • When Using

    Stop Use And See A Doctor If
    you are experiencing severe allergic reactions, local ulcers, heavy rash, edema or severe pain.
    KEEP OUT OF REACH OF CHILDREN

  • Keep Oot Of Reach Of Children

    Do not place the product within the reach of unconscious persons.

  • Directions

    ●Wash wart and surrounding skin with rubbing alcohol or astringent solution (e.g.: Potassium Permanganate solution), and dry the area thoroughly.
    ●Apply a small amount of liquid solution onto the wart with a cotton swab, and press the wart 2-3 times. Avoid applying on healthy skin.
    ●Do not apply the liquid over 1 ml onto the affected area. After applying, let the affected area dry.
    ●Use once in the morning and evening continuously for 7 days. The wart will begin to fall off after the last day of treatment. stop using, and observe for 3 days.
    *Repeat the treatment p rocess if the wart has not yet fallen off.
    If swallowed, rinse immediately with water, and get medicalhelp or contact a poison control center right away

  • Other information

    ●Keep away from direct sunlight or heat
    ●Store in room temperature (59-860F / 15-300C)

  • Inactive ingredients

    Cortex Phellodendri, Chinensis, Radix Isatidis, Radix Arnebiae,Semen Coicis, Carthamus Tinctorius L, Angelica Sinensis,Rhizoma Chuanxiong, Crassostrea Gigas.

  • Questions

    www.drlukehealthcare.com info@drlukehealthcare.com
    408-607-3728

  • PACKAGE LABEL

    21

  • INGREDIENTS AND APPEARANCE
    DR. LUKE WART REMOVER 
    wart remover liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83176-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 mg  in 100 mL
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE ACETATE1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISATIS TINCTORIA ROOT (UNII: 8S10GFI6DX)  
    PHELLODENDRON CHINENSIS BARK (UNII: 2866QMZ434)  
    ARNEBIA GUTTATA ROOT (UNII: 9XN41J8M2D)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    COPTIS DELTOIDEA ROOT (UNII: 1UIP402HTI)  
    COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI)  
    CARTHAMUS TINCTORIUS WHOLE (UNII: 5EMV416J82)  
    PACIFIC OYSTER (UNII: FX2S0D3781)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83176-013-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product08/09/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00508/09/2023
    Labeler - Dr.luke Healthcare LLC (118868014)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr.luke Healthcare LLC118868014manufacture(83176-013) , label(83176-013)