ORAJEL DENTURE PAIN RELIEF- benzocaine, benzalkonium chloride, menthol gel

Orajel Denture Pain Relief by

Drug Labeling and Warnings

Orajel Denture Pain Relief by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride 0.1%

Benzocaine 20%

Menthol 0.7%

PURPOSE

Benzalkonium Chloride - Oral antiseptic

Benzocaine - Oral pain reliever

Menthol - Oral pain reliever

INDICATIONS & USAGE

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

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

Do not use more than directed for more than 7 days unless directed by a physician or healthcare provider

STOP USE

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 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 INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

#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)

INGREDIENTS AND APPEARANCE

ORAJEL DENTURE PAIN RELIEF 
benzocaine, benzalkonium chloride, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-765
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	26 mg  in 1 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
PECTIN (UNII: 89NA02M4RX)
PETROLATUM (UNII: 4T6H12BN9U)
GELATIN (UNII: 2G86QN327L)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-765-25	1 in 1 CARTON	07/01/2016	10/18/2019
1		1 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/01/2016

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		253933600	manufacture(10237-765)