Label: ORALABS COLD SORE TREATMENT- benzocaine 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 September 4, 2014

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  • 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: 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 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

    Front and Back of Card for OraLabs CST
  • INGREDIENTS AND APPEARANCE
    ORALABS COLD SORE TREATMENT 
    benzocaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63645-162
    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:63645-162-041 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 finalpart34808/01/2014
    Labeler - OraLabs (801824756)
    Registrant - OraLabs (801824756)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(63645-162) , LABEL(63645-162)
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