ORAJEL SEVERE TOOTHACHE MAXIMUM STRENGTH FAST-ACTING FORMULA- benzocaine liquid

Orajel Severe Toothache by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Benzocaine 20%

PURPOSE

Purpose

Oral pain reliever

INDICATIONS & USAGE

Use for the temporary relief of pain due to toothaches

WARNINGS

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
                                                                                                                                                                              

Flammable:  keep away from fire or flame. Avoid smoking during application and until product has dried
                                                                                                                                                                              

DO NOT USE

Do not use

• more than directed
• for more than 7 days unless told to do so by a dentist or doctor                   
  

                                                                                                                                                                                    

STOP USE

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

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

• remove imprinted safety seal from bottle cap

adults and children 2 years and older				Apply product with cotton swab or finger to the cavity and around gum surrounding the teeth.  Use up to 4 times daily or as directed by a dentist or doctor
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 SAFETY INFORMATION

Other information

• do not use if imprinted bottle seal is broken or missing prior to opening
• this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
• do not use continuously

INACTIVE INGREDIENT

Inactive ingredients  alcohol (54.6% by volume), flavor, polyethylene glycol, purified water, red 40, sodium saccharin, yellow 5

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

#1 ORAL PAIN RELIEVER
     FOR TOOTHACHE

Orajel                     liquid
Instant Pain Relief

for  SEVERE TOOTHACHE

MAXIMUM STRENGTH
FAST-ACTING FORMULA

NET CONTENTS 0.45 FL OZ (13.3 ML)     ORAL PAIN RELIEVER         BENZOCAINE 20%

Carton image

INGREDIENTS AND APPEARANCE

ORAJEL SEVERE TOOTHACHE  MAXIMUM STRENGTH FAST-ACTING FORMULA
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-722
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
ALCOHOL (UNII: 3K9958V90M)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-722-45	1 in 1 CARTON
1		13.3 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/21/2011

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

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	manufacture