Label: SMART SENSE COLD SORE TREATMENT- benzalkonium chloride cream

  • 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 April 8, 2013

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  • Active ingredients

    Benzalkonium chloride 0.13%
    Camphor 3%

  • Purpose

    Cold Sore/Fever Blister Treatment/First Aid Antiseptic

  • Uses

    •
    for treatment of cold sores/fever blisters on the face or lips
    •
    temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters
    •
    first aid to help protect against infection in minor cuts, scrapes, burns, and sores
  • Warnings

     
    For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician.
     
    Allergy Alert: Do not use if you are allergic to any of the ingredients in this product.
     
    When using this product avoid contact with eyes. Use only as directed.
     
    Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • Directions

    •
    clean the affected area
    •
    apply a small amount of this product to the affected area 1 to 3 times daily
    •
    rub in gently
    •
    may be covered with a sterile bandage
    •
    wash hands before and after applying cream
    •
    do not share this product with anyone
    •
    children under 12 years of age: ask a doctor
  • Other information

    store at room temperature

  • Inactive ingredients

    alcohol, aloe barbadensis leaf juice, arginine, butylparaben, cetearyl isononanoate, dipropylene glycol dicaprylate/dicaprate, ethylparaben, eucalyptus globulus leaf oil, hexyl decyl laurate, hexyldecanole, melaleuca alternifolia (tea tree) leaf oil, menthol, methylparaben, ozokerite, phenoxyethanol, poloxamer 407, propylparaben, thymol, tocopheryl nicotinate (vitamin e), zinc chloride

  • Questions or Comments?

    Call us toll-free at 1-877-242-3234 Monday-Friday, 9 a.m. to 5 p.m. EST.
    Serious side effects associated with use of this product may be reported to this number.

  • PRINCIPAL DISPLAY PANEL

    Smart Sense Cold Sore Treatment
  • INGREDIENTS AND APPEARANCE
    SMART SENSE COLD SORE TREATMENT 
    benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-407
    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
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)30 ug  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Arginine (UNII: 94ZLA3W45F)  
    Butylparaben (UNII: 3QPI1U3FV8)  
    Ceresin (UNII: Q1LS2UJO3A)  
    Cetearyl Isononanoate (UNII: P5O01U99NI)  
    Corymbia Citriodora Leaf Oil (UNII: M63U6N96EB)  
    Dipropylene Glycol Caprate/Caprylate Diester (UNII: R6G12EY23X)  
    Ethylparaben (UNII: 14255EXE39)  
    Hexyldecanol (UNII: 151Z7P1317)  
    Hexyldecyl Laurate (UNII: 0V595C1P6M)  
    Levomenthol (UNII: BZ1R15MTK7)  
    Methylparaben (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Thymol (UNII: 3J50XA376E)  
    TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)  
    Zinc Chloride (UNII: 86Q357L16B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-407-011 in 1 PACKAGE
    12 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/08/2013
    Labeler - Kmart Corporation (008965873)
    Registrant - Ranir LLC (364567615)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ranir LLC364567615REPACK(49738-407) , RELABEL(49738-407)
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