Baby Orajel Instant Teething Pain Relief

Dosage form: gel
Ingredients: BENZOCAINE 75mg in 1g
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-713

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 Ingredients       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 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

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.


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

carton image

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 GLYCOL 
WATER 
SACCHARIN SODIUM 
SORBIC ACID 
SORBITOL 
Packaging
#Item CodePackage Description
1NDC:10237-713-331 TUBE (TUBE) in 1 CARTON
19.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/15/2010
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Church & Dwight Co., Inc.043690812manufacture

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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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