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Orajel Instant Relief for Teething Pain Daytime Nighttime Twin Pack

Dosage form: kit
Ingredients: BENZOCAINE 75mg in 1g; BENZOCAINE 100mg in 1g
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-739

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.

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 children 2 years of age and older. For use in children under the age of 2, consult a physician or healthcare provider.

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 physician or healthcare provider

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 physician.

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 Orajel and spread over the gums
apply to the affected area up to 4 times daily or as directed by a physician or healthcare provider
for children under 2 years of age, ask a physician or healthcare provider

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

Orajel

Instant Relief
for Teething Pain

2 cherry flavored gels

Daytime and Nighttime
TWIN PACK

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%

Front carton image

Back carton image

ORAJEL INSTANT RELIEF FOR TEETHING PAIN DAYTIME NIGHTTIME TWIN PACK
benzocaine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10237-739

Packaging
#	Item Code	Package Description
1	NDC:10237-739-36	1 KIT (TUBE) in 1 CARTON

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

ORAJEL INSTANT RELIEF FOR TEETHING PAIN LONGER LASTING
benzocaine gel

Product Information
Item Code (Source)	NDC:10237-735
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
1	NDC:10237-735-18	5.1 g in 1 TUBE

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

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

Product Information
Item Code (Source)	NDC:10237-738
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
1	NDC:10237-738-18	5.1 g in 1 TUBE

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: 03/2012

Document Id: 1c8ff394-f120-4377-8c63-897eadcaddb6

Set id: daffe4b1-e8d9-4314-bd6f-e29d5d002990

Version: 4

Effective Time: 20120326

Church & Dwight Co., Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Orajel Instant Relief for Teething Pain Daytime Nighttime Twin Pack

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