BABY ORAJEL INSTANT RELIEF  DAYTIME NIGHTTIME TWIN PACK - benzocaine   
Church & Dwight Co., Inc.

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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 image

BABY ORAJEL INSTANT RELIEF   DAYTIME NIGHTTIME TWIN PACK benzocaine   kit

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 10237-730

Packaging # NDC Package Description Multilevel Packaging 1 10237-730-36 1 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 NDC Product Code (Source) 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 # NDC 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 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 10237-729-18 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: 03/2011Church & Dwight Co., Inc.