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 SEVERE Toothache & Gum Relief PlusTRIPLE MEDICATED

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Benzocaine 20%

Menthol 0.5%

Benzalkonium Chloride 0.1%

Purpose

Oral pain reliever

Oral Pain reliever

Antiseptic

Use

  • for the temporary relief of pain due to toothaches
  • to help protect against infection in minor oral irritation

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 - cut open tip of tube on score mark

  • Adults and children 2 years of age and over - Apply a samll amount of 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
  • 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 tube tip is cut 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
  • Orajel Severe Pain Formula will stay in place for extended duration of relief
  • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Inactive ingredients

blue 1, cellulose gum, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin

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-32503-04 #1 Oral Pain Reliever for Toothache                    Orajel Instant Pain Relief SEVERE Toothache & Gum Relief Plus TRIPLE MEDICATED

Principal Display - OJFC-32503-04
                  #1 Oral Pain Reliever for Toothache                   
                  Orajel Instant Pain Relief
                  SEVERE Toothache & Gum Relief Plus
                  TRIPLE MEDICATED

Orajel Instant Pain Relief

Benzocaine 20%, Menthol, Benzalkonium Chloride GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10237-752
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 200 mg
benzalkonium chloride 1 mg
MENTHOL 50 mg

Inactive Ingredients

Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
FD&C BLUE NO. 1
GELATIN
saccharin sodium
methyl salicylate
Mineral Oil
PECTIN
petrolatum
POLYETHYLENE GLYCOL 1000

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 7.0 in 1 TUBE
2 NDC:10237-752-25 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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