Orajel Instant Pain Relief description, usages, side effects, indications, overdosage, supplying and lots more!

Orajel Instant Pain Relief

Church & Dwight Co., 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
Orajel MAXIMUM Toothache & Oral Pain Relief 

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Benzocaine 20%

Purpose

Oral pain reliever

Use

for the temporary relief of pain due to

  • toothaches
  • canker sores
  • minor injury of the mouth and gums
  • minor irritation of the mouth and gums caused by dentures

Warnings

Allergy alert: do not use this product if you have a histoy 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 physician or healthcare provider

Stop use and ask a physician 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 -

Adults and children 2 years of age and over -

  • Hold swab with solid white tip down
  • Bend and snap open swab tip with the colored rings
  • Apply product to the cavity and around gum surrounding the teeth
  • Use up to 4 times daily or as directed by a physician or healthcare provider
  • Discard swab after application

Children under 12 years of age - Should be supervised in the use of this product

Children under 2 years of age - Ask a physician or healthcare provider

Other information

  • do not use if label seal is broken prior to purchase or if the colored rings on tip are not blue
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
  • do not use continuously

Inactive ingredients

flavor, polyethylene glycol, red 40, sodium saccharin, water, yellow 5

Questions or comments?

call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com

Principal Display - OJFC-37441-05 Touch-Free Applicator #1 Oral Pain Reliever for Toothache                    Orajel Instant Pain Relief MAXIMUM Toothache & Oral Pain Relief

Principal Display - OJFC-37441-05
                  Touch-Free Applicator
                  #1 Oral Pain Reliever for Toothache                   
                  Orajel Instant Pain Relief
                  MAXIMUM Toothache & Oral Pain Relief

Orajel Instant Pain Relief

Benzocaine 20% LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10237-755
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
POLYETHYLENE GLYCOL 1000
saccharin sodium
FD&C RED NO. 40
water
FD&C YELLOW NO. 5

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 0.15 in 1 APPLICATOR
2 NDC:10237-755-12 12 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2013-12-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.