ORAJEL INSTANT PAIN RELIEF FOR TOOTHACHE MAXIMUM STRENGTH- benzocaine gel
Church & Dwight Co., Inc.

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.

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Drug Facts

Active Ingredients

Benzocaine 20%

Benzalkonium 0.1%

Purpose

Oral pain reliever

Antispeptic

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 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 told to do so by a dentist or doctor

Stop use and ask a doctor if

swelling, rash or fever develops; irritation, pain or redness persists or worsens; symptoms do not improve in 7 days

Keep out of reach of children:

in case of overdose, get medical help or contact a Poison Control Center right away

Directions

Cut open tip if tube on score mark

Adults and children 2 years of age and over

Apply a small 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 physician or healthcare provider

Other Information • do not use if tube tip is cut prior to opening • this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can consulted • do not use continuously • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Inactive ingredients

Inactive ingredients 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 our website www orajel com

Orajel gel

Instant Pain Relief

for TOOTHACHE

MAXIMUM STRENGTH

NE WT 0.42 OZ (11.9 g) ORAL PAIN RELIEVER BENZOCAINE 20%

carton image

28313

ORAJEL INSTANT PAIN RELIEF FOR TOOTHACHE MAXIMUM STRENGTH
oral pain reliever gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10237-701
Route of Administration	TOPICAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)

#	Item Code	Package Description
Packaging
1	NDC:10237-701-12	1 in 1 CARTON
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:10237-701-25	1 in 1 CARTON
2		7 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:10237-701-42	1 in 1 CARTON
3		11.9 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	04/01/2010	02/11/2016

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

Name	Address	ID/FEI	Business Operations
Establishment
Church & Dwight Co., Inc.		043690812	manufacture(10237-701)

Revised: 2/2016

Document Id: 2b84b6dc-bd11-075f-e054-00144ff8d46c

Set id: 4792701f-67be-47ab-8ade-2d2237a7f5ff

Version: 2

Effective Time: 20160211

Church & Dwight Co., Inc.