BABY ORAJEL INSTANT TEETHING PAIN RELIEF NIGHTTIME FORMULA  - 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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Active Ingredients       
Benzocaine 7.5%

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


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

with Added Pain Reliever

New and Improved!

Instant Teething Pain Relief

Baby Orajel Nighttime Formula

Oral Pain Reliever for Teething     NET WT  0.18 OZ (5.1g) GEL


carton imagecarton image

Purpose
Oral pain reliever

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

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


BABY ORAJEL INSTANT TEETHING PAIN RELIEF NIGHTTIME FORMULA 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-715
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCYRRHIZIN, AMMONIATED 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
FD&C RED NO. 40 
SACCHARIN SODIUM DIHYDRATE 
SORBIC ACID 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:10237-715-181 TUBE ( TUBE) in 1 CARTONcontains a TUBE
15.1 g in 1 TUBEThis package is contained within the CARTON (10237-715-18)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/18/201004/23/2012

Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Church & Dwight Co., Inc.043690812manufacture

Revised: 03/2011 Church & Dwight Co., Inc.