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 TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-730
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-730-361 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 5.1 g
Part 21 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GELATIN (UNII: 2G86QN327L)  
MINERAL OIL (UNII: T5L8T28FGP)  
PECTIN (UNII: 89NA02M4RX)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRY (Cherry Flavored) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-712-185.1 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/22/2011
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GELATIN (UNII: 2G86QN327L)  
MINERAL OIL (UNII: T5L8T28FGP)  
PECTIN (UNII: 89NA02M4RX)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRY (Cherry Flavored) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-729-185.1 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/18/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/22/201104/24/2012
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture

Revised: 3/2011
 
Church & Dwight Co., Inc.