Label: ANADENT KANKA GEL- benzocaine gel
- NDC Code(s): 27854-177-01
- Packager: BELMORA LLC
- Category: HUMAN OTC DRUG LABEL
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 April 14, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- 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. This can occur even if you have used this product before. 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
Do not use
- more than directed • for more than 7 days unless told to do so by a dentist or doctor
- for teething • in children under 2 years of age
Stop use and ask a dentist or doctor if
- swelling, rash or fever develops • irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days • allergic reaction occurs
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Directions
- Cut open tip of tube on score mark
- Adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. 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
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Other Information
- Do not use if tip is cut prior to opening
- This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
- Do not use continuously
- This formula will stay in place for extended duration of relief
- Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
- Inactive Ingredients:
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SPL UNCLASSIFIED SECTION
20% BENZOCAINE TO RELIEVE ORAL PAIN
COOLS GUM & RELIEVES IRRITATION
For toothaches
Toothache and Gum pain Relief Gel
TAMPER-EVIDENT:
Do not use if tube is cut prior to use.
Retain carton for complete product information.Distributed by Belmora LLC, 3033 Wilson Blvd. Suite 700 Arlington, VA 22201 | www.anadentusa.com
Questions/Comments please call: 1 888 779 2877 Monday to Friday 9AM - 5PM EST - Packaging
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INGREDIENTS AND APPEARANCE
ANADENT KANKA GEL
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:27854-177 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:27854-177-01 1 in 1 CARTON 04/15/2022 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 04/15/2022 Labeler - BELMORA LLC (112753244)