BABY ORAJEL TEETHING MEDICINE  - benzocaine liquid 
Church & Dwight Co., Inc.

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DRUG FACTS

Active ingredient      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 and 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,
remove imprinted bottle safety seal from bottle
use your fingertip or cotton applicator to apply 2-4 drops of BABY ORAJEL,
apply to the affected area up to four times daily or as told to do so by a dentist or doctor,
for infants under 4 months of age, ask a dentist or doctor

Other information
Do not use if imprinted bottle safety seal is broken or missing

Inactive ingredients  ammonium glycyrrhizate, chamomilla recutita (mtricaria) flower extract, flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, red 40, sodium saccharin, sorbic acid, sorbitol

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

Baby Orajel Liquid Teething Medicine

Carton image

Carton image


BABY ORAJEL TEETHING MEDICINE 
benzocaine   liquid
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)10237-711
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE.075 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCYRRHIZIN, AMMONIATED 
MATRICARIA RECUTITA 
GLYCERIN 
METHYLPARABEN 
POLYETHYLENE GLYCOL 
PROPYLPARABEN 
WATER 
FD&C RED NO. 40 
SACCHARIN SODIUM 
SORBIC ACID 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
110237-711-451 BOTTLE In 1 CARTONcontains a BOTTLE
113.3 mL In 1 BOTTLEThis package is contained within the CARTON (10237-711-45)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/29/2010

Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Accupac071609663manufacture
Revised: 07/2010Church & Dwight Co., Inc.