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Orajel Instant Pain Relief Maximum

Medically reviewed on May 25, 2017

Dosage form: gel
Ingredients: BENZOCAINE 200mg in 1g, MENTHOL 26mg in 1g
Labeler: Church Dwight Co., Inc.
NDC Code: 10237-762

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%

Menthol 0.26%

Purpose

Oral pain reliever

Oral pain reliever

Use
  • for the temporary relief of pain due to minor irritation or injury of the mouth and gums

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
  • do not use continuously

ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid

Questions or comments call us at 800 952 5080 Monday through Friday 9 to 5 ET or visit at www orajel com

#1 Oral Pain

Reliever Brand

For Toothache

New Formula!

2x more

active ingredients

ORAJEL

Instant Pain Relief

MAXIMUM

Toothache Relief

DOUBLE MEDICATED

20% Benzocaine to Relieve Oral Pain

Menthol to Sooth Gums NEW

Fast-Acting

GEL

NET WT. 0.25 OZ (7.0 g)

ORAJEL INSTANT PAIN RELIEF   MAXIMUM
benzocaine 20%, benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-762
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL26 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
AMMONIUM GLYCYRRHIZATE 
POLYETHYLENE GLYCOL 1000 
SACCHARIN SODIUM 
SORBIC ACID 
Packaging
#Item CodePackage Description
1NDC:10237-762-121 TUBE in 1 PACKAGE
13.5 g in 1 TUBE
2NDC:10237-762-251 TUBE in 1 CARTON
27 g in 1 TUBE
3NDC:10237-762-421 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 finalpart35607/27/2016
Labeler - Church Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Church Dwight Co., Inc.043690812manufacture(10237-762)

 
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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