HYVEE COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [HYVEE]

HYVEE COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) CREAM [HYVEE]
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NDC 42507-406-01
Set ID 38899205-1463-4c07-a2d6-fdbe57fb5a9f
Category HUMAN OTC DRUG LABEL
Packager Hyvee
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Cold Sore/Fever Blister Treatment/First Aid Antiseptic

  • Uses


    • For treatment of cold sores/fever blisters on the face or lips
    • Helps relieve the symptoms of itching, burning and pain associated with cold sores/fever blisters in just one day
    • Relieves dryness and softens cold sores and 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. If swallowed, get medical help or contact a Poison Control Center right away. (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
    • 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, Camphor, Cetearylisononanoate, Dipropylenglycole Dicaprylate-Dicaprate, Ethylparaben, Eucalyptus Globulus Leaf Oil, Hexyldecanole, Hexyl Decyl Laurate, Menthol,
    Methylparaben, Ozokerite, Phenoxyethanol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Poloxamer 407, Propylparaben, Tocopheryl Nicotinate (Vitamin E), Thymol, 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

    image of carton label

  • 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.

  • INGREDIENTS AND APPEARANCE
    HYVEE COLD SORE TREATMENT 
    benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-406
    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
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Arginine (UNII: 94ZLA3W45F)  
    Butylparaben (UNII: 3QPI1U3FV8)  
    Camphor (Synthetic) (UNII: 5TJD82A1ET)  
    Cetearyl Isononanoate (UNII: P5O01U99NI)  
    Dipropylene Glycol Caprate/Caprylate Diester (UNII: R6G12EY23X)  
    Ethylparaben (UNII: 14255EXE39)  
    Corymbia Citriodora Leaf Oil (UNII: M63U6N96EB)  
    Hexyldecanol (UNII: 151Z7P1317)  
    Hexyldecyl Laurate (UNII: 0V595C1P6M)  
    Levomenthol (UNII: BZ1R15MTK7)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Ceresin (UNII: Q1LS2UJO3A)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Alpha-Tocopherol (UNII: H4N855PNZ1)  
    Thymol (UNII: 3J50XA376E)  
    Zinc Chloride (UNII: 86Q357L16B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42507-406-011 in 1 PACKAGE
    12 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2012
    Labeler - Hyvee (006925671)
    Registrant - Ranir LLC (364567615)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ranir LLC364567615label

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