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

Flammable: keep away from fire or flame.  Avoid smoking during application and until this product has dried

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 - cut open tip of tube on score mark

  • Adults and children 2 years of age and over - Apply product with cotton swab or finger to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
  • Children under 12 years of age - Should be supervised in the use of this product
  • Children under 2 years of age - Ask a physicaian or healthcare provider

Other information

  • do not use if imprinted bottle seal is broken or missing prior to opening
  • this preparation is inteded for use in cases of toothache, only as a temporary expedient until a physician can be consulted
  • do not use continuously

Inactive ingredients

alcohol (54.6% by volume), 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-32945-04 #1 Oral Pain Reliever for Toothache                    Orajel Instant Pain Relief MAXIMUM Toothache & Oral Pain Relief 20% Benzocaine to Relieve Oral

Principal Display - OJFC-32945-04
                  #1 Oral Pain Reliever for Toothache                   
                  Orajel Instant Pain Relief
                  MAXIMUM Toothache & Oral Pain Relief
                  20% Benzocaine to Relieve Oral

Orajel Instant Pain Relief

Benzocaine 20% LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10237-754
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
ALCOHOL
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 13.3 in 1 BOTTLE, GLASS
2 NDC:10237-754-45 1 in 1 CARTON

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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