BABY ORAJEL NIGHTTIME INSTANT RELIEF FOR TEETHING PAIN LONG LASTING EXTRA STRENGTH - benzocaine gel 
Church & Dwight Co., Inc.

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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 image

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

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 10237-729-19 1 TUBE In 1 CARTON contains a CARTON (10237-729-18) 1 10237-729-18 1 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: 03/2011Church & Dwight Co., Inc.