Label: KANK-A MOUTH PAIN- benzocaine liquid
- NDC Code(s): 10157-9477-1
- Packager: Blistex Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 26, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
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. 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 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.
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Directions
- adults and children 2 years of age and older:
- 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: do not use
- adults and children 2 years of age and older:
- Other information
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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
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INGREDIENTS AND APPEARANCE
KANK-A MOUTH PAIN
benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-9477 Route of Administration BUCCAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) POLYOXYL-10 OLEYL ETHER (UNII: JD797EF70J) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CASTOR OIL (UNII: D5340Y2I9G) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) TANNIC ACID (UNII: 28F9E0DJY6) Product Characteristics Color ORANGE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10157-9477-1 9.75 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 12/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 12/01/2011 Labeler - Blistex Inc. (005126354) Establishment Name Address ID/FEI Business Operations Blistex Inc. 005126354 MANUFACTURE(10157-9477)
