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Name:Baby Orajel Nighttime Instant Relief For Teething Painlong Lasting Extra Strength
Manufacturer:Church & Dwight Co., Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BABY ORAJEL NIGHTTIME INSTANT RELIEF FOR TEETHING PAIN LONG LASTING EXTRA STRENGTH - 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

Benzocaine 10%

Purpose

Oral pain reliever

Use

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



Warnings

Allergy alert:  do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

do not use       
  • more that directed
  • for more than 7 days unless directed 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 persists, consult your doctor.

                                                                                                                                                                              

Stop use and ask a doctor if      

  • sore mouth symptoms do not improve 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 4 times daily or as directed by a dentist or doctor
  • for infants under 4 months, ask a dentist or doctor

Other information   do not use if tube tip is cut prior to opening.

Inactive ingredients   cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, red 40, sodium saccharin

Questions or comments?  call s at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com

Principal Display Panel

No. 1 TEETHING BRAND
        used by Pediatricians


        Baby
        Orajel
        Nighttime

Instant Relief for Teething Pain                            cherry flavored gel

NEW and IMPROVED
    FORMULA

LONGER LASTING          EXTRA STRENGTH  for Nighttime

NET WT 0.18 OZ (5.1g) GEL            ORAL PAIN RELIEVER FOR TEETHING       BENZOCAINE 10%

Carton imageCarton image


BABY ORAJEL NIGHTTIME INSTANT RELIEF FOR TEETHING PAIN  LONG LASTING EXTRA STRENGTH
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-729
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 100 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM  
GELATIN  
MINERAL OIL  
PECTIN  
PETROLATUM  
POLYETHYLENE GLYCOL  
FD&C RED NO. 40  
SACCHARIN SODIUM  
Product Characteristics
Color red Score     
Shape Size
Flavor CHERRY (Cherry Flavored ) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10237-729-19 1 CARTON ( TUBE) in 1 CARTON contains a CARTON (10237-729-18)
1 NDC:10237-729-18 1 TUBE ( TUBE) in 1 CARTON This package is contained within the CARTON (10237-729-19) and contains a TUBE
1 5.1 g in 1 TUBE This package is contained within a CARTON (10237-729-18) and a CARTON (10237-729-19)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 06/18/2010

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

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



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


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