LEADER ORAL ANALGESIC description, usages, side effects, indications, overdosage, supplying and lots more!

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LEADER ORAL ANALGESIC

Cardinal Health

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredient                                                                Purpose

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

Purpose

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

Uses

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

CIN 4527156

www.myleader.com

1-800-200-6313

Made in Korea

LEADER ORAL ANALGESICEnter section text here

LEADER ORAL ANALGESIC

BENZOCAINE GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-122
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 20 g

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
polyethylene glycol 400
saccharin sodium
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20 in 1 TUBE
2 NDC:37205-122-12 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partB part333B 2012-05-01


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Be sure to consult your doctor before taking any medication!
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