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

Oral Analgesic

Meijer Distribution, Inc.
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

Uses

Uses    temporarily relieves pain associated with:

toothache         minor dental procedures

Warnings

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

Do not use   

Stop use and ask a physician if   

Keep out of reach of children:

in case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Directions  

do not use if tube is cut prior to opening;  cut open tip of tube on score mark

Adults and children 2 years of age and over                  Apply a small amount of product to the cavity and around gum surrounding the teeth.
                                                                                 Use up to 4 times daily or as directed by a dentist or physician







Other information 

Inactive ingredients

Inactive ingredients  flavor, polyethylene glycol, sodium saccharin, sorbic acid

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

Orajel         gel

Instant Pain Relief

for TOOTHACHE

MAXIMUM STRENGTH



NE WT 0.42 OZ (11.9 g)     ORAL PAIN RELIEVER   BENZOCAINE 20%


Oral Analgesic

Oral Pain Reliever GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41250-701
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
saccharin sodium
sorbic acid

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 7.1 in 1 TUBE
2 NDC:41250-701-25 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2010-05-13


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Be sure to consult your doctor before taking any medication!
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