BABY ORAJEL INSTANT TEETHING PAIN RELIEF  - 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 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 doctorif 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,
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.


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

Cherry
Flavored Gel

INSTANT
TEETHING
PAIN
RELIEF

Baby Orajel      Teething Pain Medicine
Oral Pain Reliever for Teething  Net Wt. 0.33 oz (9.4g) Gel

carton image
carton image

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.

Inactive ingredients ammonium glycyrrhizate, FD and C red no. 40, flavor, glycerin, polyethylene glycol, purified water, sodium saccharin, sorbic aid, sorbitol


BABY ORAJEL INSTANT TEETHING PAIN RELIEF 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-713
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 
FD&C RED NO. 40 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
SACCHARIN SODIUM DIHYDRATE 
SORBIC ACID 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:10237-713-331 TUBE ( TUBE) in 1 CARTONcontains a TUBE
19.4 g in 1 TUBEThis package is contained within the CARTON (10237-713-33)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/15/201004/23/2012

Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Church & Dwight Co., Inc.043690812manufacture

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