ORAL ANALGESIC MAXIMUM STRENGTH- oral pain reliever gel

Oral Analgesic by

Drug Labeling and Warnings

Oral Analgesic by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution, Inc., Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Uses

Uses    temporarily relieves pain associated with:

toothache         minor dental procedures

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 physician if    swelling, rash or fever develops; irritation, pain or redness persists or worsens

Keep out of reach of children:

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

Directions

Directions  

do not use if tube is cut prior to opening;  cut open tip of 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 dentist or physician

Children under 12 years of age                                     Should be supervised in the use of this product

Children under 2 years of age                                       Ask a dentist or doctor



Other information  This preparation is intended for use in case of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously.

Inactive ingredients

Inactive ingredients  flavor, polyethylene glycol, sodium saccharin, sorbic acid

QUESTIONS

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

Orajel         gel

Instant Pain Relief

for TOOTHACHE

MAXIMUM STRENGTH

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

carton image

INGREDIENTS AND APPEARANCE

ORAL ANALGESIC  MAXIMUM STRENGTH
oral pain reliever gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-701
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
polyethylene glycol (UNII: 3WJQ0SDW1A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
sorbic acid (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-701-25	1 in 1 CARTON
1		7.1 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/13/2010

Labeler - Meijer Distribution, Inc. (006959555)

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture