Label: ALPHA-CAINE TOPICAL ANESTHETIC- benzocaine gel

  • NDC Code(s): 55346-2901-1
  • Packager: Dental Technologies, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2023

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  • Active ingredient

    Benzocaine 20%

  • Purpose

    Oral Anesthetic

  • Uses

    For the temporary relief of occasional minor irritation and pain, associated with:

    • Sore mouth and throat
    • Ulcers
    • Minor dental procedures
    • Needle punctures
    • Minor irritation of the mouth and gums caused by dentures or orthodontic appliances

  • Warnings

    For external use only

  • 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:

    • pale, gray or blue colored skin (cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy
  • Allergy alert:

    Do not use if you have a history of allergy to any “caine” anesthetics, such as benzocaine, butacaine, procaine or tetracaine.

  • Sore throat warning:

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

  • Do not use

    • for teething
    • in children under 2 years of age
  • When using this product

    avoid contact with eyes

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

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

  • Directions

    do not exceed recommended dosage.

    • adults and children 2 years of age and older: apply to affected area. Gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by dentist or doctor.
    • children under 12 years of age: should be supervised in the use of the product.
    • children under 2 years of age: do not use
  • Other information

    Store at 59° to 86º F (15º to 30º C)

  • Inactive ingredients

    Blue 1*, flavor, PEG-8, PEG-75, Red 3*, Red 33*, Red 40*, sodium saccharin, Yellow 10*

    *contains one or more of these ingredients.

  • Questions or comments?

    1-800-835-0885 or 1-847-677-5500 M-F 8:00 a.m. – 4:30 p.m. CST.

    Visit www.dentaltech.com

  • Principal Display Panel

    DENTAL

    TECHNOLOGIES

    www.dentaltech.com

    ALPHA-CAINE

    TOPICAL ANESTHETIC GEL

    DENTAL TECHNOLOGIES, INC.

    Lincolnwood, IL 60712

    Made in U.S.A.

    DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

    20% Benzocaine Oral Anesthetic

    1oz. (30g)

    Alpha-Caine_Strawberry_image.jpg

  • INGREDIENTS AND APPEARANCE
    ALPHA-CAINE  TOPICAL ANESTHETIC
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55346-2901
    Route of AdministrationPERIODONTAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRY (Strawberry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55346-2901-130 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/31/1999
    Labeler - Dental Technologies, Inc. (148312838)
    Registrant - Dental Technologies, Inc. (148312838)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dental Technologies, Inc.148312838manufacture(55346-2901) , pack(55346-2901) , label(55346-2901)
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