Label: CICLOFERON- benzalkonium chloride and lidocaine hydrochloride gel

  • NDC Code(s): 59208-002-04, 59208-002-05
  • Packager: Laboratorios Liomont, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 16, 2019

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  • Active Ingredients

    Benzalkonium Chloride 0.13%

    Lidocaine Hydrchloride 2%

  • Purpose

    Topical antiseptic

    Topical analgesic

  • Uses

    • provides temporary relief of pain associated with cold sores and fever blisters
      • first aid to help protect against infection in minor cuts, scrapes, burns
  • Warnings

    For external use only:

    Do not use in the eyes or apply over large areas of the body. In case of deep puncture wounds, animal bites, or serious burns, consult a doctor.

  • Do not use

    • for more than 7 days unless told to do so by a doctor
    • more than directed
    • if you are allergic to any ingredient in this product
  • When using this product

    • avoid contact with the eyes
  • Stop use and ask a doctor if

  • Keep out of reach of children

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

  • Directions

    • clean the affected area
    • apply a small amount of this product to the affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 12 years of age, consult a doctor
  • Other Information

    • store at 20° to 25°C (68° to 77°F)
  • Inactive Ingredients

    hypromellose, methylparaben, propylene glycol, water, polysorbate 80

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    CICLOFERON 
    benzalkonium chloride and lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59208-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59208-002-041 in 1 CARTON05/01/2019
    14 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:59208-002-051 in 1 CONTAINER05/01/2019
    24 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2019
    Labeler - Laboratorios Liomont, S.A. de C.V. (810347807)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Liomont, S.A. de C.V.810347807manufacture(59208-002)
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