BABY ORAJEL SMARTDOSE TEETHING  - 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 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 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,
before using the first time, prime pump by depressing firmly several times
to dispsnse, firmly press pump once onto fingertip or cotton applicator
apply to the affected area up to four times daily or as directed by doctor,
for infants under 4 months of age, ask a dentist or doctor

Other information
do not use if outer blister on card is torn or cut before first use

Inactive ingredients
ammonium glycyrrhizate, flavor, glycerin, polyethylene glycols, 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

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BABY ORAJEL SMARTDOSE TEETHING  benzocaine   gel

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 10237-749 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   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 10237-749-22 1 BOTTLE In 1 BLISTER PACK contains a BOTTLE, PUMP 1 6.2 g In 1 BOTTLE, PUMP This package is contained within the BLISTER PACK (10237-749-22)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/22/2010

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

Establishment
Name	Address	ID/FEI	Operations
Accupac		071609663	manufacture

Revised: 07/2010Church & Dwight Co., Inc.