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
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients                  



Purpose

Purpose
Oral antiseptic
Oral pain reliever
Pral astringent

Uses

Use    for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums. To help protect against infection in minor oral irritation.

Warnings

Allergy Alert
do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzcaine or other "caine" anesthetics

Do not use
more than is directed
for more than 7 days unless directed by a dentist or doctor

Stop use and ask a doctor if
sore mouth symptoms do not improve in 7 days
swelling, rash or fever develops
irritation, pain or redness persists or worsens


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







Inactive ingredients


Questions or comments?1-800-952-5080 www.orajel.com

Principal Display - carton

TRIPLE MEDICATED for FAST
EFFECTIVE RELIEF  


Orajel 

For all Mouth Sores

MAXIMUM STRENGTH



carton imagePrincipal Display - carton

Orajel Instant Pain Relief

Benzocaine GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10237-708
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
benzalkonium chloride 0.4 mg
BENZOCAINE Benzocaine 200 mg
ZINC CHLORIDE 1 mg

Inactive Ingredients

Ingredient Name Strength
ALLANTOIN
CARBOMER 934
EDETATE DISODIUM
PEPPERMINT OIL
polyethylene glycol
POLYSORBATE 60
propylene glycol
PROPYL GALLATE
water
POVIDONE K30
saccharin sodium
sorbic acid
stearyl alcohol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 11.9 in 1 TUBE
2 5.1 in 1 TUBE
3 3.5 in 1 TUBE
4 NDC:10237-708-12 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2010-06-11


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Be sure to consult your doctor before taking any medication!
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