Label: ZICLOVIN ORAL PAIN RELIEF- benzalkonium chloride, benzocaine gel

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 14, 2024

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  • Drug Facts

  • Active ingredients & Purposes

    Active ingredients Purposes
    Benzalkonium chloride 0.1%........................Topical antiseptic
    Benzocaine 20%..........................................Fever blister and cold sore treatment

  • Uses

    For the temporary relief of pain due to

    • fever blisters
    • cold sores
    • antiseptic to help prevent infection
  • Warnings

    For external use only. Avoid contact with the eyes.

    Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

    • pale, gray, or blue colored skin (cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

    Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

    Do not use

    • longer than 1 week
    • on large areas of the body
    • in the eyes

    Ask a doctor before use

    • in case of deep or puncture wounds, animal bites, or serious burns

    When using this product

    • you may feel a brief stinging sensation after application that will go away shortly thereafter

    Stop use and ask a dentist or doctor if

    • a rash or irritation develops
    • condition persists or worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older: Clean the affected area. Apply a small amount to affected not more than 3 times daily. May be covered with a sterile bandage. If bandaged, let first dry.

    • children under 2 years of age: do not use, consult a doctor
  • Other information

    • store between 68-77°F (20-25°C)
  • Inactive ingredients

    ammonium glycyrrhizate, carboxymethylcellulose sodium, FD&C yellow #6, glycerin, polyethylene glycol, saccharin sodium, sorbic acid, water

  • Questions?

    Dist. by/por: PHARMADEL LLC

    New Castle, DE 19720

    Questions? +1-866-359-3478

  • PRINCIPAL DISPLAY PANEL

    PDP Ziclovin Oral Pain

  • INGREDIENTS AND APPEARANCE
    ZICLOVIN  ORAL PAIN RELIEF
    benzalkonium chloride, benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-438
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SORBIC ACID (UNII: X045WJ989B)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-438-011 in 1 CARTON11/12/2024
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/12/2024
    Labeler - Pharmadel LLC (030129680)
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