Orajel Instant Pain Reliver for Canker Sores

Orajel Instant Pain Reliver for Canker Sores by

Drug Labeling and Warnings

Orajel Instant Pain Reliver for Canker Sores by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., Accupac. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORAJEL INSTANT PAIN RELIVER FOR CANKER SORES EXTRA STRENGTH PAIN RELIEF- benzocaine, menthol 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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Orajel Instant Pain Reliver for Canker Sores

Active Ingredients

Benzocaine 15%

Menthol 2%

Purpose

Oral pain reliever

Use

Use for the temporary relief of pain associated with minor irritation or injury of the mouth and gums; canker sores

Warnings

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

Flammable: keep away from fire or flame. Avoid smoking during the application and until product has dried.

Do not use more than directed; for more than 7 days unless directed by a dentist or doctor

Stop use and ask a doctor if

• sore mouth symptoms do not improve in 7 days
• swelling, reash or fever develops
• irritaion, pain or redness persists or worsens

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

• cut open tip of tube on score mark
• do not use if tube tip is cut prior to opening
• do not peel off protective film
• use up to 4 times daily or as directed by a dentist or doctor

Adults and children 2 years of age and over                   Dry affected area. Apply with cotton swab or finger.  Allow gel to dry for 30-60 seconds into a protective film.

Children under 12 years of age                                      Should be supervised in the use of this product

Children under 2 year of age                                         Ask a dentist or doctor

Inactive ingredients acesulfame potassium, alcohol (76.4% by volume), ethylcellulose, flavor, polycarbophil, water

Questions or comments? callus at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com.

Principal Display Panel

#1 PHARMACIST

RECOMMENDED

Brand for Adult Oral Pain

Film Forming

gel

Orajel

Instant Pain Relief

FOR CANKER SORES

PROTECTIVE SHIELD

EXTRA STRENGTH PAIN RELIEF

SAFETY SEALED TUBE TIP

NET WT 0.33 OZ (9.4 g) ORAL PAIN RELIEVER

ORAJEL INSTANT PAIN RELIVER FOR CANKER SORES  EXTRA STRENGTH PAIN RELIEF
benzocaine, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-707
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	150 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME (UNII: MA3UYZ6K1H)
ALCOHOL (UNII: 3K9958V90M)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
POLYCARBOPHIL (UNII: W25LM17A4W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-707-33	1 in 1 CARTON	07/29/2010	12/31/2019
1		9.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/29/2010	12/31/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
Accupac		071609663	manufacture(10237-707)

Revised: 1/2020

Document Id: 9ce5d39b-036d-beb9-e053-2995a90ab1df

34390-5

Set id: c7936cbc-b132-4025-8439-8227b928c2fd

Version: 3

Effective Time: 20200124