Orajel Instant Pain Relief - Regular Strength

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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORAJEL INSTANT PAIN RELIEF REGULAR STRENGTH- 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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Orajel Instant Pain Relief - Regular Strength

Active ingredient

Benzocaine 10%

Purpose

Oral pain reliever

Do not use

• more than is directed

• for more than 7 days unless told to do so by a dentist or doctor

Stop use and ask a doctor if

• swelling, rash or fever develops

• irritation, pain or redness persists or worsens

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

Use for the temporary relief of pain due to toothaches

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

Keep out of reach of children
In case of overdose, 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 a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by dentist or doctor


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


Children under 2 years of age: Ask a dentist or doctor

Other information

• do not use if tube tip is cut prior to opening

• this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
• do not use continuously

Inactive ingredients ammonium glcyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid

#1 ORAL PAIN RELIEVER

FOR TOOTHACHE

gel

NEW

LOOK!

Orajel

Instant Pain Relief

FOR TOOTHACHE

REGULAR STRENGTH

SAFETY SEALED TUBE TIP

NET WT 0.33 OZ (9.4 g) ORAL PAIN RELIEVER BENZOCAINE 10%

ORAJEL INSTANT PAIN RELIEF  REGULAR STRENGTH
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-704
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-704-33	1 in 1 CARTON	06/10/2010	12/31/2019
1		9.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10237-704-25	1 in 1 CARTON	06/10/2010	12/31/2019
2		7 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	06/10/2010	12/31/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-704)

Revised: 1/2020

Document Id: 9caa0dd1-d3a1-637c-e053-2a95a90af908

34390-5

Set id: 574c7911-e24b-4b52-b01f-df89d58fd505

Version: 3

Effective Time: 20200121

 

Church & Dwight Co., Inc.