Label: ALPHA-CAINE TOPICAL ANESTHETIC- benzocaine gel 

  • NDC Code(s): 55346-2902-1
  • Packager: Dental Technologies, 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 01/14

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

  • Active ingredient

    Benzocaine 20%

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  • Purpose

    Oral Anesthetic

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  • 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
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  • Warnings

    For external use only

    Allergy alert: Do not use if you have a history of allergy to any "caine" anesthetics, such as benzocaine, butacaine, procaine, or tetracaine.

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  • 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.

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  • When using this product

    avoid contact with eyes

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  • Stop use and ask a doctor if

    you experience any of the following symptoms, as these may be a sign of methemoglobinemia, a rare disorder which can appear up to 2 hours after use:

    • pale, gray or blue-colored skin, lips and nail beds
    • shortness of breath
    • fatigue
    • confusion
    • headache
    • light-headedness
    • rapid heart rate

    If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • Keep out of reach of children.

    If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

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  • ´╗┐Directions

    • do not exceed recommended dosage.

    • adults and children 2 years of age and older: Apply to the 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 a dentist or doctor.

    • children under 12 years of age: Should be supervised in the use of the product.

    • children under 2 years of age: Consult a dentist or doctor.
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  • Other information

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

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  • Inactive ingredients

    Blue 1, flavor, PEG-8, PEG-75, sodium saccharin, Yellow 10

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  • ´╗┐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

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  • Principal Display Panel

    DENTAL TECHNOLOGIES

    www.dentaltech.com

    ALPHA-CAINE®

    TOPICAL ANESTHETIC GEL

    20% Benzocaine Oral Anesthetic

    MINT

    1 oz. (30g)

    REF 029.0201.002

    image description

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  • SPL UNCLASSIFIED SECTION

    DENTAL TECHNOLOGIES, INC.

    Lincolnwood, IL 60712

    Made in U.S.A.

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

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  • INGREDIENTS AND APPEARANCE
    ALPHA-CAINE  TOPICAL ANESTHETIC
    benzocaine gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55346-2902
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzocaine (Benzocaine) Benzocaine 200 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Polyethylene Glycol 400  
    Polyethylene Glycol 3350  
    SACCHARIN SODIUM  
    FD&C BLUE NO. 1  
    D&C YELLOW NO. 10  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT (Mint) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55346-2902-1 30 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 12/31/1999
    Labeler - Dental Technologies, Inc. (148312838)
    Registrant - Dental Technologies, Inc. (148312838)
    Establishment
    Name Address ID/FEI Business Operations
    Dental Technologies, Inc. 148312838 manufacture(55346-2902), pack(55346-2902), label(55346-2902)
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