ORAJEL FOR TOOTHACHE MAXIMUM STRENGTH- benzocaine swab

Orajel for Toothache by

Drug Labeling and Warnings

Orajel for Toothache by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., SwabPlus, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                    Purpose
Benzocaine 20%                   Oral Pain Reliever

Uses for the temporary relief of pain due to toothaches

Warnings
Allergy Alert
do not use this product if your 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 dentist of doctor if symptoms do not get better in 7 days; swelling, rash or fever develops; irritation, pain or redness persists or worsens

Keep out of reach of children. in case of overdose or allergic reaction, get medical help or contact a Poison Control Center right awayEnter section text here

Directions

Adults and Children                     Hold swab with solid white tip down
2 years of age and older              Bend and snap open swab tip with the colored rings
                                                 Apply product to the cavity and around gum surrounding the                                                     teeth
                                                 Use up to 4 times daily or as directed by a dentist or doctor
                                                 Discard swab after application

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 do not use if label seal is broken prior to purchase, or if colored rings on tip are not blue, this preparation is intended for use in cases of toothache, only as temporary expedient until a dentist can be consulted, do not use continuously

Inactive ingredients flavor, polyethylene glycol, purified water, red 40, sodium saccharin, yellow 5

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

Carton image

INGREDIENTS AND APPEARANCE

ORAJEL FOR TOOTHACHE  MAXIMUM STRENGTH
benzocaine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-705
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.2 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-705-12	12 in 1 CARTON
1		1.8 mL in 1 APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/11/2010

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

Establishment
Name	Address	ID/FEI	Business Operations
SwabPlus, Inc.		876441549	manufacture