ORAJEL INSTANT PAIN RELIEF REGULAR- benzocaine 10% gel

Orajel Instant Pain Relief by

Drug Labeling and Warnings

Orajel Instant 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

Benzocaine 20%

Purpose

Oral pain reliever

Use

• for the temporary relief of pain due to toothaches

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

Do not use

• more than directed
• for more than 7 days unless directed by a physician or healthcare provider

ASK DOCTOR

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN:

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

DOSAGE & ADMINISTRATION

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
• this preparation is inteded for use in cases of toothache, only as a temporary expedient until a physician can be consulted
• do not use continuously

Inactive ingredients

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

Questions or comments?

call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com

PRINCIPAL DISPLAY PANEL

#1 ORAL PAIN

RELIEVER BRAND

FOR TOOTHACHE

Orajel

MEDICATED

FOR TOOTHACHE

INSTANT PAIN RELIEF

Relieves Oral Pain with 10% Benzocaine

NET WT

0.25 oz (7.0 g)

INGREDIENTS AND APPEARANCE

ORAJEL INSTANT PAIN RELIEF  REGULAR
benzocaine 10% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-745
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-745-25	1 in 1 PACKAGE	12/01/2013
1		2.5 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	12/01/2013

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

Establishment
Name	Address	ID/FEI	Business Operations
Church Dwight Co., Inc.		043690812	manufacture(10237-745)