BABY ORAJEL TEETHING PAIN MEDICINE - 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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DRUG FACTS

Active Ingredients       
Benzocaine 7.5%       

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


Questions(?)  call 1-800-952-5080 M-F 9am-5pm ET

Tube imageTube image

Use temporarily relieves sore gums due to teething in infants and children 4 months of age and older.

Inactive ingredients  ammonium glycyrrhizate, flavor, glycerin, polyethylene glycol, purified water, red 40, sodium saccharin, sorbic acid, sorbitol

BABY ORAJEL TEETHING PAIN MEDICINE 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-751
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-751-185.1 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/20/201004/24/2012
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture

Revised: 7/2010
 
Church & Dwight Co., Inc.