Label: ORAJEL FOR COLD SORES SINGLE DOSE- benzalkonium chloride and benzocaine liquid 

  • Label RSS
  • NDC Code(s): 10237-741-04
  • Packager: Church & Dwight Co., Inc.
  • 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 04/12

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    Benzalkonium chloride, 0.13%
    Benzocaine, 5%

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  • PURPOSE

    PURPOSE

    Cold Sore / Fever Blister Treatment; Topical Antiseptic
    Pain Relief During Applications

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  • INDICATIONS & USAGE

    USES
    • to treat cold sores / fever blisters
    • to help guard against infection
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  • WARNINGS

    WARNINGS

    For external use only. Flammable, keep away from fire or flame.

    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
    • in the eyes
    • over large areas of the body
    • if you are allergic to any ingredient in the product
    • more than 3 times per day
    • longer than one week unless directed by a physician
    Stop use and ask a dentist or physician if
    • condition persists or worsens
    • symptoms persist for more than 7 days
    Ask a physician if
    • used to treat deep or puncture wounds, animal bites, or serious burns
    • you are pregnant or nursing a baby
    When using this product you may feel a brief stinging sensation when applying it. The sting should go away in a short time.
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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUR OF REACH OF CHILDREN

    In case of overdose, or allergic reaction, get medical help or contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

    DIRECTIONS
    Adults and children over 2 years of age:
    • Clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics including lipstick using only warm water or alcohol
    • Slide off to remove the protective blue paper cover and slide it on the other end-opposite the white applicator tip
    • Squeeze the vial firmly on the arrow shown on the blue paper cap until you hear it snap
    • Hold with the white applicator tip down to allow the medication to saturate the tip
    • To minimize pain during application gently touch the site of the cold sore with the saturated applicator tip. Once the area is numb, rub the site of the cold sore and the surrounding area.  Rub firmly to allow the treatment to deeply penetrate the skin.
    • To treat most cold sores, usually one treatment is enough.  If your symptoms go away and then return later, apply another dose for the second cold sore
    • Do not use more than 3 times per day
    • Discard after use.
    Children under 2 years of age: ask a dentist or physician.

    OTHER INFORMATION
    • Store at room temperature
    • The ingredients in toothpaste, soft drinks, and some fruit juices can de-activate the active ingredient in Orajel Single Dose.
    • For best results, avoid brushing your teeth with toothpaste or drinking soft drinks or fruit juices for one hour after applying the drug.
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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS
    isopropyl alcohol (70% v/v), water

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  • QUESTIONS

    Questions or coments? call us at 1-800-952-5080 M-F ET or visit our website at www.orajel.com

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  • PRINCIPAL DISPLAY PANEL

    NEW
    Orajel

    Instant Pain Relief

    FOR COLD SORES

    ONE DAY, ONE DOSE,
    HEALING BEGINS

    SINGLE DOSE
    Patented Cold Sore Treatment

    CONTAINS 2 ONE DAY TREATMENT VIALS         TOPICAL ANTISEPTIC/TOPICAL ANESTHETIC
    NET 0.04 FL OZ (1.2 mL) Total                                TOUCH-FREE APPLICATOR

    Package Front
    Package Front

    Package Back
    Package Back
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  • INGREDIENTS AND APPEARANCE
    ORAJEL FOR COLD SORES  SINGLE DOSE
    benzalkonium chloride, benzocaine liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10237-741
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 mg  in 1 mL
    BENZOCAINE (BENZOCAINE) BENZOCAINE 0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL ALCOHOL  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10237-741-04 2 in 1 PACKAGE
    1 0.6 mL in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 07/01/2012
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    Name Address ID/FEI Business Operations
    James Alexander Corporation 040756421 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Berkeley Contract Packaging, LLC 807293576 pack
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