ORAJEL INSTANT RELIEF FOR TEETHING PAIN LONGER LASTING- benzocaine gel
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

Benzocaine 7.5%

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 child 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, consult 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

1-800-952-5080

M-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

cherry flavored gel

LONGER LASTING

NET WT 0.33 OZ (9.4g) Gel ORAL PAIN RELIEVER FOR TEETHING BENZOCAINE 7.5%

Carton image

ORAJEL INSTANT RELIEF FOR TEETHING PAIN LONGER LASTING
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10237-735
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	75 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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
Color	red	Score
Shape		Size
Flavor	CHERRY (cherry flavored)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10237-735-18	5.1 g in 1 TUBE; Type 0: Not a Combination Product	03/22/2011	05/29/2018
2	NDC:10237-735-12	1 in 1 CARTON	03/22/2011	05/29/2018
2		3.5 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:10237-735-42	1 in 1 CARTON	03/22/2011	05/29/2018
3		11.9 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:10237-735-33	1 in 1 CARTON	03/22/2011	05/29/2018
4		9.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	03/22/2011	05/29/2018

Labeler - Church & Dwight Co., Inc. (001211952)

Name	Address	ID/FEI	Business Operations
Establishment
Church & Dwight Co., Inc.		043690812	manufacture(10237-735)

Revised: 5/2018

Document Id: 6d5cc418-ce6c-6564-e053-2a91aa0aeb43

Set id: 38746f16-ce52-4d56-9657-a1e8e19649ee

Version: 2

Effective Time: 20180529

Church & Dwight Co., Inc.