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Orajel Instant Pain Relief Maximum

Medically reviewed on November 13, 2017

Dosage form: gel
Ingredients: BENZOCAINE 200mg in 1g, BENZALKONIUM CHLORIDE 1mg in 1g
Labeler: Church Dwight Co., Inc.
NDC Code: 10237-746

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 MAXIMUM Toothache Relief
DOUBLE MEDICATED

Active ingredient

Benzocaine 20%

Benzalkonium Chloride 0.1%

Purpose

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
  • allergic reaction occurs

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
  • avoid using toothpaste or drinking soft drinks or fruit juices for a t least one hour after applying

Inactive ingredients

ammonium glycyrrhizate, 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

Principal Display - OJFC-28313-06

#1 Oral Pain Reliever
 for Toothache                   

Orajel Instant Pain Relief

MAXMUM Toothache Relief

DOUBLE MEDICATED
20% Benzocaine to Relieve Oral Pain
Antiseptic to Help Prevent Infections

ORAL PAIN RELIEVER/ANTISEPTIC       NET WT 0.42 OZ (11.0g)           FAST-ACTING GEL

ORAJEL INSTANT PAIN RELIEF  MAXIMUM
benzocaine 20%, benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-746
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
AMMONIUM GLYCYRRHIZATE 
POLYETHYLENE GLYCOL 1000 
SACCHARIN SODIUM 
SORBIC ACID 
Packaging
#Item CodePackage Description
1NDC:10237-746-121 TUBE in 1 PACKAGE
13.5 g in 1 TUBE
2NDC:10237-746-251 TUBE in 1 CARTON
27 g in 1 TUBE
3NDC:10237-746-421 TUBE in 1 CARTON
311.9 g in 1 TUBE
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
Church Dwight Co., Inc.043690812manufacture(10237-746)

 
Church Dwight Co., Inc.

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Further information

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

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