WALGREENS COLD SORE TREATMENT (BENZOCAINE) OINTMENT [WALGREENS]

WALGREENS COLD SORE TREATMENT (BENZOCAINE) OINTMENT [WALGREENS]
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NDC 0363-3191-01
Set ID 67d18f83-eb96-42ae-90f4-883f3bca0b77
Category HUMAN OTC DRUG LABEL
Packager Walgreens
Generic Name
Product Class
Product Number
Application Number PART348
  • Active ingredient

    Benzocaine

  • Purpose

    Cold Sore/Fever Blister Treatment/Pain Reliever

  • Keep Out of Reach of Children

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

  • Uses

    For treatment of cold sores/fever blisters on the face and lips

  • Warnings

    For external use only: Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butocaine, benzocaine, or other “caine: anesthetics.

    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.

    When using this product avoid contact with eyes. Use only as directed.

    Stop use and ask a doctor if the condition gets worse. Do not use longer than 1 week unless directed by a doctor.

  • Directions

    Clean the affected

    Adults and children 2 years of age and older: Apply to affected area not more than 4 times daily

    Children under 2 years of age: consult a physician

    Rub in gently – Applies clear

    Wash hands before and after applying cream

    Do not share this product with anyone

  • Inactive Ingredients

    Benzyl Alcohol, Docosanol, Mineral Oil, Propylene Glycol, Sucrose Stearate, Tocopherol, Water.

  • Package/Label Principal Display Panel

    Well at Walgreens Cold Sore Treatment
  • INGREDIENTS AND APPEARANCE
    WALGREENS COLD SORE TREATMENT 
    benzocaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3191
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5.00 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 2.00 mg  in 1 g
    DOCOSANOL (UNII: 9G1OE216XY) 10 mg  in 1 g
    BENZYL ALCOHOL (UNII: LKG8494WBH) 9.00 mg  in 1 g
    SUCROSE STEARATE (UNII: 274KW0O50M) 5.00 mg  in 1 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 4.99 mg  in 1 g
    WATER (UNII: 059QF0KO0R) 64 mg  in 1 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-3191-011 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2015
    Labeler - Walgreens (008965063)
    Registrant - Walgreens (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(0363-3191) , LABEL(0363-3191)

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