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LEADER ORAL ANALGESIC

Medically reviewed on July 7, 2017

Dosage form: gel
Ingredients: BENZOCAINE 20g in 100g
Labeler: CARDINAL HEALTH
NDC Code: 37205-122

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.

Active ingredient                                                                Purpose

Benzocaine 20%................................................................Oral Pain Reliever

Uses

  • temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters, minor irritation of the mouth and gums cause by dentures or orthodontic appliances

Warnings

Allergy alert: do not use this product if you have a history of allergic to local anesthetics such as procaine, butacaine, benzocaine, or other caine anesthetics

Do not use

  • more than directed
  • for more than 7 days unless directed by a doctor/dentist

Stop use and ask a doctor if

  • swelling, rash, or fever develops
  • irritation, pain, or redness persists or worsens
  • symptoms do not improve in 7 days

Keep out of reach of children.

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

Directions

  • remove cap and cut tip of tube on score mark
  • adults and children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a doctor or dentist
  • children under 12 years of age: should be supervised when using this product
  • children under 2 years of age: ask a doctor/dentist

Other information

  • store at 15o to 25oC (59o to 77oF)
  • do not use if tube tip is cut prior to opening
  • this preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist can be consulted
  • do not use continuously
  • Lot no and Exp. Date: see box or see crimp of tube

Inactive ingredients

d-sorbitol solution, flavor, glycerin, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium hydrate

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Made in Korea

LEADER ORAL ANALGESIC 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-122
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 4000 
SACCHARIN SODIUM 
Packaging
#Item CodePackage Description
1NDC:37205-122-121 TUBE in 1 CARTON
111.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B05/01/2012
Labeler - CARDINAL HEALTH (097537435)

 
CARDINAL HEALTH

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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