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Name:Baby Orajel Instant Relief Daytime Nighttime Twin Pack
Manufacturer:Church & Dwight Co., Inc.
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

BABY ORAJEL INSTANT RELIEF  DAYTIME NIGHTTIME TWIN PACK - 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

Active ingredients

Daytime                     Nighttime
Benzocaine 7.5%               Benzocaine 10%              

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 your 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 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 persist, 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 of age, 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 us at 1-800-952-5080M-F 9am-5pm ET or visit our website at www.orajel.com

Principal Display Panel

No 1 TEETHING BRAND
        used by Pediatricians

                                                         Baby
                                            Orajel

                                         Instant Relief
                                       for Teething Pain

                                                                                                                  2 cherry flavored gels

                                              Daytime and Nighttime
                                                   TWIN PACK

NEW AND IMPROVED
FORMULA

            LONGER LASTING                                                                              LONGER LASTING
                                                                                                                Extra Strength for NIghttime

ORAL PAIN RELIEVER FOR TEETHING
               BENZOCAINE 7.5%         2 TUBES NET WT 0.18 OZ (5.1G) EACH           BENZOCAINE 10%

Carton imageCarton image


BABY ORAJEL INSTANT RELIEF   DAYTIME NIGHTTIME TWIN PACK
benzocaine kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-730
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10237-730-36 1 KIT ( TUBE) 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 INSTANT RELIEF FOR TEETHING PAIN  LONGER LASTING
benzocaine gel
Product Information
Item Code (Source) NDC:10237-712
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
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 10237-712-18 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 03/22/2011

Part 2 of 2
BABY ORAJEL NIGHTTIME INSTANT RELIEF FOR TEETHING PAIN  LONG LASTING EXTRA STRENGTH
benzocaine gel
Product Information
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 10237-729-18 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 06/18/2010


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 03/22/2011

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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