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

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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, get medical help or contact a Poison Control Center right away.

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.
Keep in refrigerator for extra cooling.
Do not freeze.

Inactive ingredients  ammonium glycyrrhizate, cucumis sativus (cucumber) fruit extract, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium saccharin, sorbic acid, sorbitol, sucralose

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  benzocaine   gel

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 10237-710 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (BENZOCAINE) BENZOCAINE 75 mg  in 1 g

Inactive Ingredients Ingredient Name Strength GLYCYRRHIZIN, AMMONIATED   CUCUMBER   GLYCERIN   POLYETHYLENE GLYCOL   PROPYLENE GLYCOL   WATER   SACCHARIN SODIUM   SORBIC ACID   SORBITOL   SUCRALOSE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10237-710-00 1 TUBE In 1 CARTON contains a TUBE 1 9.4 g In 1 TUBE This package is contained within the CARTON (10237-710-00)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/15/2010

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

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

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