Label: CORNEX- lactic acid, salicylic acid gel

  • NDC Code(s): 82160-238-01
  • Packager: Pella Pharmaceuticals Co. Ltd
  • 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 June 20, 2022

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  • Active Ingredients

    Each one gram contains: Lactic acid 167mg and salicylic acid 167mg.

  • Composition

    Excipients: Alcohol, Hydroxypropyl Cellulose.

  • Properties

    Cornex is a topical gel for the removal of warts and corns.

  • Indications

    Cornex is used to remove Warts and Corns. A wart is a viral infection of the skin surface layer. The incubation period varies from a few weeks to several months. Warts can be spread by contact of the virus with damaged skin, particularly if warm and moist. This is why one of the most common sources of infection is swimming pools. Corns are hard, thick pads of skin caused by pressure and friction. They usually occur on the feet due to poorly fitting shoes. They can also occur on hands. Cornex Gel is suitable for use by adults, children and the elderly.

  • Contraindications

    Cornex is contraindicated in patients with known hypersensitivity to lactic acid and / or salicylic acid or to any other components of this product.
    Do not use Cornex if you are diabetic or suffer from poor blood circulation to your hands or feet.

  • Precautions

    Cornex is formulated for the controlled corrosion of keratin and thus care should be taken to apply the product to the wart only. Avoid applying it to normal surrounding skin. Do not use Cornex on the face, mucous membranes or anogenital reagions. Cornex is not recommended for use in infants under 2 years of age. Children under 12 years should only use the product under supervision.

    Precaution

    As well all the medicines you should keep Cornex out of reach of children.

  • Drug Interactions

    No interaction betyween Lactic acid and Salicylic acid and other drugs or substances are known or suspected.

  • Warnings

    Remember that warts are infectious. To prevent the infection spreading to others always keep to your own towel. Do not walk about barefoot if warts are on the soles of your feet. Be patient, it can take 6 to 12 weeks to completely remove the wart. Do not use Cornex on moles, brithmarks or unusual skin growths or near eyes or on mucous membranes.

    Avoid use on broken or inflamed skin.

  • Dosage and Administration

    Remove any plaster and soak the wart in hot water for five minutes. Dry with your own towel. Rub the surface of the warts carefully with a pumice stone or emery board. Apply Cornex daily to the warts. Use only enough Cornex to cover the warts and avoid applying to the surrounding normal skin.

    Allow Cornex to dry and cover with plaster if the wart is large or on foot. Continue using Cemex daily until the wart is completely cleared and the ridge lines of the skin have been restored.

  • Side Effects

    Avoid use on large areas of skin; as this may result in absorption of sufficient quantities to cause adverse effects.

  • Storage

    Store below 30 " C.

  • How supplied

    15 g packs.

  • Secondary Package

    Secondary Package

  • Primary Package

    Primary Package

  • INGREDIENTS AND APPEARANCE
    CORNEX 
    lactic acid, salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82160-238
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID2505 mg  in 15 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2505 mg  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82160-238-011 in 1 CARTON03/25/2010
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03003/25/2010
    Labeler - Pella Pharmaceuticals Co. Ltd (562370925)