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Orajel Instant Pain Relief SEVERE

Medically reviewed on November 20, 2017

Dosage form: liquid
Ingredients: BENZOCAINE 200mg in 1g
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-753

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Orajel SEVERE Toothache & Oral Pain Relief 

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-32531-03

#1 Oral Pain Reliever
 for Toothache                   

Orajel Instant Pain Relief

SEVERE 
Toothache & Oral Pain Relief

20% Benzocaine to Relieve Oral Pain
Toothache        Canker Sores
Gum Pain          Denture Pain
Cheek Bites


ORAL PAIN RELIEVER       0.45 FL. OZ (13.3ML)           FAST-ACTING LIQUID

ORAJEL INSTANT PAIN RELIEF  SEVERE
benzocaine 20% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-753
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
POLYETHYLENE GLYCOL 1000 
SACCHARIN SODIUM 
FD&C RED NO. 40 
WATER 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:10237-753-451 BOTTLE, GLASS in 1 CARTON
113.3 g in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/01/2013
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Accupac071609663manufacture(10237-753)

 
Church & Dwight Co., Inc.

← See all Orajel Instant Pain Relief SEVERE brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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