BABY ORAJEL TEETHING PAIN RELIEF  - benzocaine swab 
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 ingredient         

Benzocaine 7.5%

Purpose
Oral Pain Reliever

Use
for the temporary relief of sore gums due to teething in infants and children 4 months of age and older

Warnings
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

hold swab with solid white tip down

bend and snap open swab tip at the colored rings.  Throw away the broken off end before use.  Wait 30-40 seconds for product to flow down into swab tip
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 label seal is broken prior to purchase, or if colored rings on tip are not pink

inactive ingredients flavor, polyethylene glycol, purified water, red 33 sodium saccharin

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 Teething Swabs

Instant Teething Pain Relief

12 unit dose swabs  Net wt. 0.06 FL OZ (1.8mL) EACH

Carton image
Carton image

BABY ORAJEL TEETHING PAIN RELIEF 
benzocaine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-717
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE.075 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOLS 
WATER 
D&C RED NO. 33 
SACCHARIN SODIUM DIHYDRATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:10237-717-1212 APPLICATOR ( SWAB) in 1 CARTONcontains a APPLICATOR
11.8 mL in 1 APPLICATORThis package is contained within the CARTON (10237-717-12)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/01/201004/24/2012

Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
SwabPlus, Inc.876441549manufacture

Revised: 08/2010 Church & Dwight Co., Inc.