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Name:Baby Orajel Daytime Regular Formula And Nighttime Formula
Manufacturer:Church & Dwight Co., Inc.
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

BABY ORAJEL DAYTIME REGULAR FORMULA AND NIGHTTIME FORMULA  - benzocaine   
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

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Use temporarily relieves sore gums due to teething in infants and children 4 months of age and 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.


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

Questions or Comments?

call us at 1-800-952-080 M-F 9am-5pm ET or visit our website at www.orajel.com

Daytime and Nighttime

New and Improved!

Instant Teething Pain Relief

#1 Teething Brand Used By Pediatricians

Twin Pack

Regular Formula Baby Orajel Safety Sealed Tube Tips Nighttime Formula

Oral Pain Reliever for Teething

Regular Formula                                                                              Nighttime Formula
Benzocaine 7.5%         2 TUBES NEW WT 0.18OZ (5.1g) EACH        Benzocaine 10%

Carton image

Carton image


BABY ORAJEL DAYTIME REGULAR FORMULA AND NIGHTTIME FORMULA 
benzocaine kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-716
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10237-716-36 1 KIT ( KIT) in 1 CARTON None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE   5.1 g
Part 2 1 TUBE   5.1 g
Part 1 of 2
BABY ORAJEL TEETHING PAIN MEDICINE 
benzocaine gel
Product Information
Item Code (Source) NDC:10237-751
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 75 mg  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 10237-751-18 5.1 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 07/20/2010

Part 2 of 2
BABY ORAJEL INSTANT TEETHING PAIN RELIEF NIGHTTIME FORMULA 
benzocaine gel
Product Information
Item Code (Source) NDC:10237-715
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 100 mg  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 10237-715-18 5.1 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 07/20/2010


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 07/20/2010

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

Revised: 07/2010 Church & Dwight Co., Inc.



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


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