BABY ORAJEL SMARTDOSE TEETHING  - benzocaine gel 
Church & Dwight Co., Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients
Benzocaine 7.5%

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.

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

Purpose
Oral pain reliever

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

Baby Orajel Instant Relief for Teething Pain
Smartdose

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BABY ORAJEL SMARTDOSE TEETHING 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-749
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCYRRHIZIN, AMMONIATED 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
FD&C RED NO. 40 
SACCHARIN SODIUM DIHYDRATE 
SORBIC ACID 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:10237-749-221 BOTTLE, PUMP ( BOTTLE) in 1 BLISTER PACKcontains a BOTTLE, PUMP
16.2 g in 1 BOTTLE, PUMPThis package is contained within the BLISTER PACK (10237-749-22)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/22/201004/24/2012

Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Accupac071609663manufacture

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