Orajel SEVERE Toothache & Oral Pain Relief

Orajel Instant Pain Relief by

Drug Labeling and Warnings

Orajel Instant Pain Relief 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 RELIEF SEVERE- benzocaine 20% liquid 
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 SEVERE Toothache & Oral Pain Relief

Active ingredients

Benzocaine 20%

Purpose

Oral pain reliever

Use

for the temporary relief of pain due to

• toothaches
• canker sores
• minor injury of the mouth and gums
• minor irritation of the mouth and gums caused by dentures

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 application and until this product has dried

Do not use

• more than directed
• for more than 7 days unless directed by a physician or healthcare provider

Stop use and ask a physician if

• swelling, rash or fever develops
• irritation, pain or redness persists or worsens
• symptoms do not improve in 7 days

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

• Adults and children 2 years of age and over - Apply product with cotton swab or finger to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
• Children under 12 years of age - Should be supervised in the use of this product
• Children under 2 years of age - Ask a physician or healthcare provider

Other information

• do not use if imprinted bottle seal is broken or missing prior to opening
• this preparation is inteded for use in cases of toothache, only as a temporary expedient until a physician can be consulted
• do not use continuously

Inactive ingredients

alcohol (54.6% by volume), flavor, polyethylene glycol, red 40, sodium saccharin, water, yellow 5

Questions or comments?

call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com

#1 Oral Pain Reliever
for Toothache

NEW LOOK!

Orajel

Instant Pain Relief

SEVERE
Toothache & Oral Pain Relief

20% Benzocaine to Relieve Oral Pain

Toothache Canker Sores

Gum Pain Denture Pain

Cheek Bites

ORAL PAIN RELIEVER 0.45 FL. OZ (13.3ML) FAST-ACTING LIQUID

ORAJEL INSTANT PAIN RELIEF  SEVERE
benzocaine 20% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-753
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-753-45	1 in 1 CARTON	12/01/2013	12/31/2019
1		13.3 g in 1 BOTTLE, GLASS; 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	12/01/2013	12/31/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
Accupac		071609663	manufacture(10237-753)

Revised: 1/2020

Document Id: 9cbba2f9-19b5-ed74-e053-2a95a90adb03

34390-5

Set id: 707d27da-731c-4726-9c77-63fcc071d09d

Version: 2

Effective Time: 20200122

 

Church & Dwight Co., Inc.