ANADENT CHILDRENS KANKA GEL- eugenol gel 
Belmora LLC

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.

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AnaDent Children's Kanka Gel

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

PAIN RELIEF

For toothaches

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

www.anadentusa.com

Packaging

Anadentgel-178

ANADENT CHILDRENS KANKA GEL 
eugenol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-178
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL12 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27854-178-011 in 1 CARTON11/08/2022
17 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/08/2022
Labeler - Belmora LLC (112753244)

Revised: 11/2022
Document Id: d2dfd707-8d68-45dd-9e32-d7cc34a500be
Set id: 9c06211c-f05a-4ce7-89e5-63a63efb7f96
Version: 1
Effective Time: 20221108
 
Belmora LLC