Oral Analgesic description, usages, side effects, indications, overdosage, supplying and lots more!

Oral Analgesic

LIFElabs, a Division of Atico International USA, INC.

  • 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
LIFElabs, a Division of Atico International USA, INC.

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Oral Analgesic (Maximum Strength)

Active Ingredient

Benzocaine 20%

Purpose

Purpose

Oral pain reliever


Uses

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

Warnings

for temporary use only until a dentist can be consulted



Allergy alert:

do not use this product if you have a history of allergy to local anesthetics such a procaine, butacaine, benzocaine or other "caine" anesthetics.

Uses

When using this product

  • do not use more than directed
  • do not use for more than 7 days unless directed by a doctor/dentist
  • do not use more than 4 times in a 24 hour period unless directed by a doctor/dentist

Stop use and ask a doctor if

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

Keep out of reach of children.

In cases of overdose, 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 year of age: should be supervised in the use of this product
  • children under 2 years of age: ask a doctor/dentist

Other information

  • store at 15o to 25o (50o to 77oF)
  • 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, glycerin, peppermint flavor, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium

Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.






Oral Analgesic

Benzocaine GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51852-101
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 200 mg

Inactive Ingredients

Ingredient Name Strength
sorbitol
GLYCERIN
PEPPERMINT
polyethylene glycol 400
POLYETHYLENE GLYCOL 4000
saccharin sodium

Product Characteristics

Color
white

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 11.9 in 1 TUBE
2 NDC:51852-101-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2010-11-01


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