Orajel MAXIMUM Toothache Relief - Double Medicated

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 MAXIMUM- benzocaine 20%, benzalkonium chloride gel 
Church and 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 MAXIMUM Toothache Relief - Double Medicated

Active ingredient

Benzocaine 20%

Menthol 0.26%

Purpose

Oral pain reliever

Oral pain reliever

Use

• for the temporary relief of pain due to minor irritation or injury of the mouth and gums

Warnings

Allergy alert: do not use this product if you have a histoy 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

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
• allergic reaction occurs

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 a samll amount of product 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 physicaian or healthcare provider

Other information

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

ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid

Questions or comments call us at 800 952 5080 Monday through Friday 9 to 5 ET or visit at www orajel com

#1 Oral Pain

Reliever Brand

For Toothache

New Formula!

2x more

active ingredients

ORAJEL

Instant Pain Relief

MAXIMUM

Toothache Relief

DOUBLE MEDICATED

20% Benzocaine to Relieve Oral Pain

Menthol to Sooth Gums NEW

Fast-Acting

GEL

NET WT. 0.25 OZ (7.0 g)

ORAJEL INSTANT PAIN RELIEF  MAXIMUM
benzocaine 20%, benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-762
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
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	26 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-762-12	1 in 1 PACKAGE	07/27/2016	12/31/2019
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10237-762-25	1 in 1 CARTON	07/27/2016	12/31/2019
2		7 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 10237-762-42	1 in 1 CARTON	07/27/2016	12/31/2019
3		11.9 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	07/27/2016	12/31/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
Church Dwight Co., Inc.		043690812	manufacture(10237-762)

Revised: 1/2020

Document Id: 9cbc711a-12a7-6b24-e053-2995a90a2784

34390-5

Set id: 38a00691-7290-08a7-e054-00144ff8d46c

Version: 6

Effective Time: 20200122