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  5. Label Information: Kank-a Mouth Pain

FDA Label for Kank-a Mouth Pain

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. ALLERGY ALERT
    7. WHEN USING THIS PRODUCT
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL - 9.75 ML BOTTLE PACKAGE

Kank-a Mouth Pain Product Label

The following document was submitted to the FDA by the labeler of this product Blistex Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Active Ingredient



Benzocaine 20.0% (w/w)


Purpose



Oral anesthetic/analgesic


Uses



  • for the temporary relief of pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums

Warnings



For oral 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.


When Using This Product



  • do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your doctor or dentist promptly.
  • do not exceed recommended dosage.

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • to assure formation of a long-lasting film coating, dry affected area and apply medication undiluted with applicator
  • allow a few seconds for coating to form
  • 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 this product
    • children under 2 years of age: consult a dentist or doctor

Other Information



  • do not purchase if package has been opened
  • cap tightly after use to avoid evaporation
  • avoid contact with the eyes
  • avoid contact with clothing and household/ furniture surfaces to prevent possible staining
  • this is a personal care item, and should be used by one individual only

Inactive Ingredients



benzyl alcohol, cetylpyridinium chloride, compound benzoin tincture, dimethyl isosorbide, ethylcellulose, flavor, octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer, oleth-10, PEG-6, propylene glycol, ricinus communis (castor) seed oil, SD alcohol 38B (29.6% v/v), sodium saccharin, sucralose, tannic acid


Principal Display Panel - 9.75 Ml Bottle Package



NDC 10157-9477-1

PROFESSIONAL
STRENGTH

Blistex®

KANK-A®
Mouth Pain Liquid
ORAL ANESTHETIC

SAVE
$100
NOW
See Inside Back Panel

Maximum Pain Relief

Forms Protective Coating

For Sores Inside the Mouth

  •  Canker Sores
  •  Denture Abrasions
  •  Brace Irritation

    • ADA
    Accepted
    American
    Dental
    Association
    ®

    CONVENIENT
    CONTROL-TIP
    APPLICATOR

    .33 FL OZ (9.75 mL)


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