Home – Orajel Instant Pain Relief for Severe Toothache

Orajel Instant Pain Relief for Severe Toothache

Church & Dwight Co., Inc.

DRUG FACTS

FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients Prupose

Benzocaine 20% Oral pain reliever

Menthol 0.5% Oral pain reliever

Purpose

Use for the temporary relief of pain due to toothaches

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

Stop use and ask a doctor if

Keep out of reach of children
Directions

Other information

Inactive Ingredients

Questions or comments? 1-800-952-5080 www.orajel.com

Carton image

Orajel Instant Pain Relief for Severe Toothache

Benzocaine and Menthol GEL

Product Information
Product Type	Human otc drug label	Item Code (Source)	NDC:10237-724
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE Benzocaine		200 mg
MENTHOL		5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1
CARBOXYMETHYLCELLULOSE SODIUM
GELATIN
methyl salicylate
PECTIN
polyethylene glycol
saccharin sodium

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.0 in 1 TUBE
2	NDC:10237-724-25	1 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
part	part356	2010-07-21

PLEASE, BE CAREFUL!

Be sure to consult your doctor before taking any medication!