ORAJEL INSTANT PAIN RELIEF REGULAR- benzocaine 10% 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 Regular Mild Toothache Relief

Active ingredient

Benzocaine 20%

Purpose

Oral pain reliever

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

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

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 BRAND

FOR TOOTHACHE

Orajel

MEDICATED

FOR TOOTHACHE

INSTANT PAIN RELIEF

Relieves Oral Pain with 10% Benzocaine

NET WT

0.25 oz (7.0 g)

DA2008700_OJFC-22240-07_72013308

ORAJEL INSTANT PAIN RELIEF  REGULAR
benzocaine 10% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-745
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-745-251 in 1 PACKAGE12/01/2013
12.5 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 finalpart35612/01/2013
Labeler - Church Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church Dwight Co., Inc.043690812manufacture(10237-745)

Revised: 1/2023
Document Id: fb0e5d38-d110-43cc-bc27-a1de6aeba29c
Set id: 5e81d2e2-cfc6-4de8-a441-fbb994e1205b
Version: 3
Effective Time: 20230120
 
Church Dwight Co., Inc.