ORAJEL INSTANT PAIN RELIEF SEVERE- benzocaine 20%, menthol, benzalkonium chloride cream 
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 & Gum Relief Plus

TRIPLE MEDICATED

Active ingredient

Benzocaine 20%

Menthol 0.25%

Benzalkonium Chloride 0.1%

Purpose

Oral pain reliever

Oral Pain reliever

Antiseptic

Use

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

Stop use and ask a physician if

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

Other information

Inactive ingredients

cellulose gum, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, 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

#1

ORAL PAIN

Reliever for

Toothache

Now with 3X MORE

Active Ingredients vs. Store Brand

ORAJEL™

Instant Pain Relief

SEVERE

Toothache & Gum Relief Plus

Triple Medicated

20% Benzocaine to Relieve Oral Pain

Antiseptic to Help Prevent Infection

Menthol to Soothe

Oral Pain Reliever NET WT 0.33 OZ (9.4g)

Long-Lasting Cream

OJFC-32501-06

OJFC-32501-06.jpg

ORAJEL INSTANT PAIN RELIEF  SEVERE
benzocaine 20%, menthol, benzalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-747
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GELATIN (UNII: 2G86QN327L)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
MINERAL OIL (UNII: T5L8T28FGP)  
PECTIN (UNII: 89NA02M4RX)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-747-321 in 1 CARTON02/27/2017
19.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/27/2017
Labeler - Church Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church Dwight Co., Inc.043690812manufacture(10237-747)

Revised: 4/2017
Document Id: 4ce932f7-46fe-2caf-e054-00144ff88e88
Set id: 4ce932f7-46fd-2caf-e054-00144ff88e88
Version: 5
Effective Time: 20170411
 
Church Dwight Co., Inc.