Medication Guide App

Baby Orajel Teething Medicine

Generic Name: benzocaine
Dosage Form: topical liquid

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.

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

Baby Orajel Teething Medicine 
benzocaine liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-711
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE .075 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCYRRHIZIN, AMMONIATED  
MATRICARIA RECUTITA  
GLYCERIN  
METHYLPARABEN  
POLYETHYLENE GLYCOL  
PROPYLPARABEN  
WATER  
FD&C RED NO. 40  
SACCHARIN SODIUM  
SORBIC ACID  
SORBITOL  
Packaging
# Item Code Package Description
1 NDC:10237-711-45 1 BOTTLE (BOTTLE) in 1 CARTON
1 13.3 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 07/29/2010
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
Name Address ID/FEI Operations
Accupac 071609663 manufacture
Revised: 07/2010
 
Church & Dwight Co., Inc.



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