ANADENT CHILDRENS KANKA GEL- eugenol gel

AnaDent Childrens Kanka Gel by

Drug Labeling and Warnings

AnaDent Childrens Kanka Gel by is a Otc medication manufactured, distributed, or labeled by Belmora LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

QUESTIONS

Questions/Comments please call: 1 888 779 2877 Monday to Friday 9AM - 5PM EST

SPL UNCLASSIFIED SECTION

PAIN RELIEF

For toothaches

Distributed by Belmora LLC, 3033 Wilson Blvd. Suite 700 Arlington, VA 22201

www.anadentusa.com

Packaging

INGREDIENTS AND APPEARANCE

ANADENT CHILDRENS KANKA GEL 
eugenol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27854-178
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW)	EUGENOL	12 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27854-178-01	1 in 1 CARTON	11/08/2022
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	11/08/2022

Labeler - Belmora LLC (112753244)