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Orajel Denture Pain Relief by Church & Dwight Co., Inc.

Medically reviewed on December 16, 2016

Dosage form: gel
Ingredients: MENTHOL 26mg in 1g, BENZOCAINE 200mg in 1g
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-765

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 Denture Pain

Benzalkonium Chloride 0.1%

Benzocaine 20%

Menthol 0.7%

Benzalkonium Chloride - Oral antiseptic

Benzocaine - Oral pain reliever

Menthol - Oral pain reliever

Use for the temporary relief of • pain due to minor irritation of the mouth and gums caused by dentures • occasional minor irritation, pain, sore mouth.

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 • 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

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

Directions

cut open tube on score mark

Adults and children 2 years of age and over:

Apply a thin layer to the affected area. Do not reinsert dental work until irritation/pain is relieved. Rinse out well before reinserting. 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 physician or healthcare provider

Other Information • do not sue if tube tip is cut prior to opening • this preparation is intended for use in cases of denture pain, only as a temporary expedent until a physician can be consulted • do not use continuously • Orajel Denture Pain Gel will stay in place for extended duration of relief

Inactive Ingredients blue 1, cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin, water

Questions or comments call us at 800 952 5080 Monday through Friday 9-5 or visit our website www orajel com

#1

Oral Pain

Reliever Brand

For Adults

New Formula!

3x More

Active Ingredients*

Orajel

Instant Pain Relief

For Denture Pain

Soothes Gum Pain & Irritation

Triple Medicated

10% Benzocaine to Relieve Pain from Dentures

Astringent to Relieve Gum Irriation NEW

Menthol to Soothe Gums Irritated by Dentures

Refreshing Mint

Long-Lasting Gel

Oral Pain Reliever/Astringent NET WT 0.25 OZ (7.0g)

ORAJEL DENTURE PAIN RELIEF 
benzocaine, benzalkonium chloride, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-765
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL26 mg  in 1 g
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
PECTIN 
PETROLATUM 
GELATIN 
MINERAL OIL 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POTASSIUM SODIUM SACCHARATE 
FD&C BLUE NO. 1 
Product Characteristics
ColorblueScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10237-765-251 TUBE in 1 CARTON
11 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/01/2016
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Church & Dwight Co., Inc.253933600manufacture(10237-765)

 
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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