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


DRUG FACTS

BABY ORAJEL SMARTDOSE TEETHING  - 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 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 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,
before using the first time, prime pump by depressing firmly several times
to dispsnse, firmly press pump once onto fingertip or cotton applicator
apply to the affected area up to four times daily or as directed by doctor,
for infants under 4 months of age, ask a dentist or doctor


Other information
do not use if outer blister on card is torn or cut before first use

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

Questions or comments?  call us at 1-800-952-5080 Mon-Fri 9am-5pm ET or visit our website at www.orajel.com

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BABY ORAJEL SMARTDOSE TEETHING 
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-749
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  
GLYCERIN  
POLYETHYLENE GLYCOL  
WATER  
FD&C RED NO. 40  
SACCHARIN SODIUM  
SORBIC ACID  
SORBITOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10237-749-22 1 BOTTLE, PUMP ( BOTTLE) in 1 BLISTER PACK contains a BOTTLE, PUMP
1 6.2 g in 1 BOTTLE, PUMP This package is contained within the BLISTER PACK (10237-749-22)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 07/22/2010

Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
Name Address ID/FEI Operations
Accupac 071609663 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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