Leader Oral Pain Relief description, usages, side effects, indications, overdosage, supplying and lots more!

Leader Oral Pain Relief

Cardinal Health
Lee Pharmaceuticals

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Benzocaine, 20%

Purpose

Oral pain reliever

Uses

For the temporary relief of minor toothache, pain and sore mouth associated with canker sores, dentures and orthodontic appliances.

Warnings

Uses

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 directed by a dentist or doctor.
Stop use and ask a Doctor if:

  • swelling, rash, or fever develops
  • irritation, pain or redness persists or gets worse

Keep Out of Reach of Children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Cut open tip of tube.

Adults and children 2 years of age and older, apply to affected area 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 the product.

Children under 2 years of age, consult a doctor.

Other Information

  • Do not use if tube tip is cut prior to opening.
  • Store at room temperature.

Inactive Ingredients

Flavors, PEG 4, PEG 540, PEG 75, PEG 8, Sodium Saccharin, Sorbic Acid.

Maximum Strength

Oral Pain Relief

Anesthetic Gel

ORAL PAIN RELIVER

BENZOCAINE 20%

0.5OZ (14.2G)

carton image

Maximum Strength

Oral Pain Relief

Anesthetic Gel

ORAL PAIN RELIVER

BENZOCAINE 20%

0.5OZ (14.2G)

tube image

Leader Oral Pain Relief

Benzocaine 20% GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-607
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 200 mg

Inactive Ingredients

Ingredient Name Strength
SACCHARIN SODIUM DIHYDRATE
sorbic acid
POLYETHYLENE GLYCOLS

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-607-05 14.2 in 1 TUBE
2 NDC:37205-607-06 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2012-08-08


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Be sure to consult your doctor before taking any medication!
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