Xylocaine Dental

Name: Xylocaine Dental

Contraindications

2% Xylocaine Dental is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to any components of the injectable formulations.

PRINCIPAL DISPLAY PANEL 1.7 mL Cartridge Carton

NDC 66312-176-16

DENTSPLY
PHARMACEUTICAL

2% Xylocaine® DENTAL
with epinephrine 1:100,000

(lidocaine HCl and epinephrine Injection, USP)

20 mg/mL

Store at room temperature
below 25°C (77°F).

DO NOT PERMIT TO FREEZE.

Rx only

50 Cartridges, 1.7 mL each

COLOR
CODED

STERILE AQUEOUS
SOLUTION FOR INJECTION

DENTSPLY Reorder #: 20016

XYLOCAINE 
lidocaine hydrochloride and epinephrine bitartrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66312-181
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride Anhydrous 20 mg  in 1 mL
Epinephrine Bitartrate (Epinephrine) Epinephrine 20 ug  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 6.5 mg  in 1 mL
Potassium Bisulfite 1.2 mg  in 1 mL
Edetate Disodium 0.25 mg  in 1 mL
Sodium hydroxide  
Hydrochloric acid  
Water  
Packaging
# Item Code Package Description
1 NDC:66312-181-16 50 CARTRIDGE in 1 CARTON
1 1.7 mL in 1 CARTRIDGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA088389 01/22/1985
XYLOCAINE 
lidocaine hydrochloride and epinephrine bitartrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66312-176
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride Anhydrous 20 mg  in 1 mL
Epinephrine Bitartrate (Epinephrine) Epinephrine 10 ug  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 6.5 mg  in 1 mL
Potassium Bisulfite 1.2 mg  in 1 mL
Edetate Disodium 0.25 mg  in 1 mL
Sodium hydroxide  
Hydrochloric acid  
Water  
Packaging
# Item Code Package Description
1 NDC:66312-176-16 50 CARTRIDGE in 1 CARTON
1 1.7 mL in 1 CARTRIDGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA088390 01/22/1985
Labeler - Dentsply Pharmaceutical (102221942)
Revised: 05/2014   Dentsply Pharmaceutical

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all uses of this drug:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of too much acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat the does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
  • Change in balance.
  • Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes.
  • Feeling very tired or weak.
  • Feeling hot or cold.
  • Feeling confused.
  • Dizziness or passing out.
  • Restlessness.
  • Anxiety.
  • Ringing in ears.
  • Blurred eyesight.
  • Seeing double.
  • Sweating a lot.
  • Seizures.
  • Trouble breathing, slow breathing, or shallow breathing.
  • Shakiness.
  • Twitching.
  • A burning, numbness, or tingling feeling that is not normal.
  • Very nervous and excitable.
  • Low mood (depression).
  • Throwing up.
  • Slow heartbeat.
  • Fever.

Spinal:

  • Trouble passing urine.
  • Loss of bladder or bowel control.
  • Change in sex ability.
  • Long-lasting burning, numbness, tingling, or paralysis in the lower half of the body.
  • Headache.
  • Backache.
  • Chills.
  • Stiff neck.
  • If bright lights bother your eyes.
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