KROGER COLD SORE TREATMENT (CAMPHOR) CREAM [THE KROGER CO.]

KROGER COLD SORE TREATMENT (CAMPHOR) CREAM [THE KROGER CO.]
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NDC 30142-408-01
Set ID a703e8d0-301a-407e-9d67-1cdf9efd8c58
Category HUMAN OTC DRUG LABEL
Packager The Kroger Co.
Generic Name
Product Class
Product Number
Application Number PART333A
  • 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?

    800-632-6900.

  • PRINCIPAL DISPLAY PANEL

    Kroger Cold Sore Treatment
  • INGREDIENTS AND APPEARANCE
    KROGER COLD SORE TREATMENT 
    camphor cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-408
    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 mg  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:30142-408-011 in 1 PACKAGE
    12 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/30/2013
    Labeler - The Kroger Co. (006999528)
    Registrant - Ranir LLC (364567615)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ranir LLC364567615RELABEL(30142-408) , REPACK(30142-408)