Label: ANBESOL COLD SORE THERAPY- allantion, benzocaine, camphor, petrolatum ointment

  • 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 November 25, 2020

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  • Active Ingredients

    Allantoin 1%

    Benzocaine 20%

    Camphor 3%

    White petrolatum 64.9%

    Purposes

    Skin protectant

    Fever blister/cold sore treatment

    Fever blister/cold sore treatment

    Skin protectant

  • Uses

    1.
    temporarily relieves pain associated with fever blisters and cold sores
    2.
    relieves dryness and softens fever blisters and cold sores
  • Warnings

    METHEMOGLOBINEMIA WARNING

    Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

    1.
    pale, gray, or blue colored skin (cyanosis)
    2.
    headache
    3.
    rapid heart rate
    4.
    shortness of breath
    5.
    dizziness or lightheadedness
    6.
    fatigue or lack of energy

    For external use only

    Allergy alert

    Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

    Do not use

    1.
    on deep or puncture wounds
    2.
    on animal bites
    3.
    on serious burns
    4.
    for teething
    5.
    in children under age 2

    When using this product

    1.
    avoid contact with the eyes
    2.
    do not exceed recommended dosage

    Stop use and ask a doctor if

    1.
    condition worsens
    2.
    symptoms persist for more than 7 days
    3.
    symptoms clear up and occur again within a few days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    1.
    to open tube, cut tip of the tube on score mark with scissors
    2.
    adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily
    3.
    children under 12 years of age: adult supervision should be given in the use of this product
    4.
    children under 2 years of age: do not use
  • Other information

    store at 20-25°C (68-77°F)

  • Inactive ingredients

    aloe barbadensis leaf extract, benzyl alcohol, butylparaben, glyceryl monostearate, isocetyl stearate, menthol, methylparaben, mineral oil, propylparaben, sodium lauryl sulfate, vitamin E, white wax

  • Questions or comments?

    Call weekdays 9AM to 5PM EST at 1-888-797-5638

  • PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack Label

    ointment
    WITH
    Vitamin E
    & Aloe

    See new warnings information

    Anbesol®
    Fever Blister/Cold Sore Treatment

    Cold Sore THERAPY

    MAXIMUM
    STRENGTH

    DOCTOR
    RECOMMENDED

    Instant
    Pain Relief

    1.
    Cold Sores and
    Fever Blisters
    2.
    Moisturizes While It
    Treats and Protects

    NET WT 0.33 OZ (9 g)

    Safety Sealed Tube:
    Do Not Use if tube tip is cut prior to opening.

    Principal Display Panel - 9 g Tube Blister Pack Label
  • INGREDIENTS AND APPEARANCE
    ANBESOL COLD SORE THERAPY 
    allantion, benzocaine, camphor, petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0246
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN10 mg  in 1 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)30 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM649 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Product Characteristics
    ColorWHITE (White ointment) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0246-251 in 1 BLISTER PACK05/09/200606/21/2010
    19 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0573-0246-261 in 1 BLISTER PACK09/15/2008
    29 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/09/2006
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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