ORAJEL ANTISEPTIC ALCOHOL-FREE MOUTH SORE RINSE- hydrogen peroxide, menthol 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 Antiseptic Alcohol-Free Mouth Sore Rinse

Active ingredients

Hydrogen peroxide 1.5%

Menthol 0.1%

Purpose

Oral debriding agent/Oral antiseptic, Oral pain reliever

Uses

Aids in the removal of:

Warnings

Do not use this product for more than 7 days unless directed by a dentist or healthcare provider

When using this product

Stop Use

Stop Use and see your physician promptly if

Keep out of reach of children

If more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center right away

Directions

Adults and children 2 years of age and older

Children under 12 years of age

Children under 2 years of age

Other information

Inactive ingredients

blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, propylene glycol, sodium saccharin, sorbitol, water

Questions or comments?

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

Principal Display Panel

#1 ORAL PAIN RELIEVER BRAND FOR ADULTS

With PAIN RELIEF!

Orajel

ALCOHOL FREE

FOR ALL MOUTH SORES

ANTISEPTIC RINSE

Canker Sores Cheek Bites Gum Irritation Irritation from Dentures or Braces

Promotes Healing

Kills Bacteria

Provides Pain Relief

SOOTHING MINT RINSE

16 FL OZ (473.2 mL)

ORAL DEBRIDING AGENT/ANTISEPTIC RINSE/PAIN RELIEVER

DA2011185_OJLBF-00003-03_72013523

ORAJEL ANTISEPTIC ALCOHOL-FREE MOUTH SORE RINSE 
hydrogen peroxide, menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-784
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 mg  in 1 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
POLOXAMER 338 (UNII: F75JV2T505)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-784-16473.2 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35611/01/2019
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Canada Corp.253933600MANUFACTURE(10237-784)

Revised: 1/2023
Document Id: cf529852-2a6e-4c86-b16b-ef30fe1211fb
Set id: 99d47d6a-fa2e-d5ee-e053-2995a90aa11d
Version: 5
Effective Time: 20230110
 
Church & Dwight Co., Inc.