FDA Label for Anadent Childrens Kanka Gel

View Indications, Usage & Precautions

Anadent Childrens Kanka Gel Product Label

The following document was submitted to the FDA by the labeler of this product Belmora Llc. 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.

Drug Facts




Active Ingredient



Eugenol 1.2%


Purpose



Toothache Relief Agent


Uses:



For the temporary relief of throbbing, persistent toothache.


Warnings:



For external use only.

Allergy alert: Do not use if you are allergic to eugenol (clove oil).

When using this product
• use only in teeth with persistent throbbing pain
• DO NOT SWALLOW to avoid irritation  • avoid contact with eyes

Do not use
• for more than 7 days  • more than the recommended dose

Stop use and ask a dentist or doctor if
• irritation persists  • inflammation develops  • fever and infection develop


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



• Adults and children 2 to 12 years of age and older: Moisten a cotton pellet with 1 or 2 drops of the product and then apply to the cotton pellet on the applicable tooth. Avoid touching tissues other than the tooth cavity. Apply the dose not more than four times daily or as directed by a dentist or physician.
• Children 2 to 12 years of age: should be supervised in the use of this product. Children under 2 years of age: use only under the advice of a dentist or physician.


Other Information



• Do not purchase if package has been opened  • Store at 46 - 90°F
• Cap tightly to avoid evaporation


Inactive Ingredients:



Ammonium Glycyrrhizate, Flavor, PEG-400, PEG-3350, Sodium Saccharin Dihydrate, Sorbic Acid


Packaging




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