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


DRUG FACTS

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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DRUG FACTS

Active ingredient          Purpose

Benzocaine 7.5%                Oral Pain Reliever

Use

for the temporary relief o f 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

Carton image

Carton image


BABY ORAJEL TEETHING PAIN RELIEF 
benzocaine swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-717
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
POLYETHYLENE GLYCOL  
WATER  
D&C RED NO. 33  
SACCHARIN SODIUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10237-717-12 12 APPLICATOR ( SWAB) in 1 CARTON contains a APPLICATOR
1 1.8 mL in 1 APPLICATOR This package is contained within the CARTON (10237-717-12)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 08/01/2010

Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
Name Address ID/FEI Operations
SwabPlus, Inc. 876441549 manufacture

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



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


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