BABY ORAJEL INSTANT TEETHING PAIN RELIEF NIGHTTIME FORMULA  - benzocaine gel 
Church & Dwight Co., Inc.

----------

Drug Facts

Active Ingredients        Purpose
Benzocaine 7.5%               Oral pain reliever

Use    for the temporary relief of sore gums due to teething in infants and children 4 months of age or older

Allergy Alert
do not use this product if our baby has 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

When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection.   If these symptoms do not go away, advise your dentist or doctor.

Stop use and ask a dentist of doctor if sore mouth symptoms do not get better in 7 days, irritation, pain or redness does not go away, swelling, rash or fever develops

Keep out of reach of children. in case of overdose or allergic reaction, Enter section text here

Directions

wash hands,

cut open tip of tube on score mark, use your fingertip or cotton applicator to apply a small pea-size amount of Baby Orajel

apply to the affected area up to four times daily or as directed by a dentist or doctor

for infants under 4 months of age, ask a dentist or doctor

Other Information

do not use if tube tip is cut prior to opening

Inactive ingredients ammonium glycyrrhitzate, flavor, glycerin, polyethylene glycol, purified water, red 40, sodium saccharin, sorbic acid, sorbitol

Questions or comments?  call us at 1-800-952-5080 Mon-Fri 9am-5pm ET or visit our website at www.orajel.com

carton image

BABY ORAJEL INSTANT TEETHING PAIN RELIEF NIGHTTIME FORMULA  benzocaine   gel

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 10237-715 Route of Administration TOPICAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength GLYCYRRHIZIN, AMMONIATED   GLYCERIN   POLYETHYLENE GLYCOL   WATER   FD&C RED NO. 40   SACCHARIN SODIUM   SORBIC ACID   SORBITOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10237-715-18 1 TUBE In 1 CARTON contains a TUBE 1 5.1 g In 1 TUBE This package is contained within the CARTON (10237-715-18)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/18/2010

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

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

Revised: 06/2010Church & Dwight Co., Inc.