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Name:Baby Orajel Instant Teething Pain Relief
Manufacturer:Church & Dwight Co., Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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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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 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 in refrigerator for extra cooling.
Do not freeze.

Inactive ingredients  ammonium glycyrrhizate, cucumis sativus (cucumber) fruit extract, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium saccharin, sorbic acid, sorbitol, sucralose

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

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BABY ORAJEL INSTANT TEETHING PAIN RELIEF 
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-710
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 75 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
GLYCYRRHIZIN, AMMONIATED  
CUCUMBER  
GLYCERIN  
POLYETHYLENE GLYCOL  
PROPYLENE GLYCOL  
WATER  
SACCHARIN SODIUM  
SORBIC ACID  
SORBITOL  
SUCRALOSE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10237-710-00 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 9.4 g in 1 TUBE This package is contained within the CARTON (10237-710-00)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 06/15/2010

Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
Name Address ID/FEI Operations
Church & Dwight Co., Inc. 043690812 manufacture

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



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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