Anadent Childrens Kanka Gel
FDA Label NDC 27854-178
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Belmora Llc for the product Anadent Childrens Kanka Gel (NDC 27854-178). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses:, warnings:, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Anadentgel-178 (27854178 1)
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