Label: WALGREENS COLD SORE TREATMENT- benzalkonium chloride and camphor (synthetic) cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Camphor 3.0%

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  • Purpose

    Cold sore/fever blister treatment/first aid antiseptic

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  • 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
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  • 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.

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  • 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

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  • 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
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  • Other Information

    store at room temperature

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  • Inactive Ingredients

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

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  • 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.

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  • INGREDIENTS AND APPEARANCE
    WALGREENS COLD SORE TREATMENT 
    camphor cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0407
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride 1.3 mg  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 30 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0407-02 1 in 1 PACKAGE
    1 2 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 07/15/2013
    Labeler - Walgreens (008965063)
    Registrant - Ranir LLC (364567615)
    Establishment
    Name Address ID/FEI Business Operations
    Ranir LLC 364567615 REPACK(0363-0407) , RELABEL(0363-0407)
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