ORAJEL 2X GUM PAIN  ALCOHOL-FREE- menthol and hydrogen peroxide rinse 
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 2x Gum Pain Rinse
Alcohol-Free

Drug Facts

Active ingredientsPurpose
Hydrogen peroxide 1.5%Oral debriding agent/Oral antiseptic
Menthol 0.1%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 do not swallow

  • do not exceed recommended dosage

Stop use and see your physician promptly if

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • sore mouth symptoms do not improve in 7 days

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 olderSwish one-half capful (2 teaspoons = 10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare provider
Children under 12 years of ageShould be supervised in the use of this product
Children under 2 years of ageConsult a dentist or healthcare provider

Other information

Inactive ingredients

disodium EDTA, FD&C blue no.1, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, propylene glycol, sodium saccharin, sorbitol, water

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 - 473.2 mL Bottle Label

1#
ORAL PAIN
RELIEF BRAND
FOR ADULTS

Orajel
2X
GUM PAIN RINSE
MEDICATED
ALCOHOL FREE

EFFECTIVE ORAL PAIN RELIEF

Soothes & Cools Gums
Kills Harmful Bacteria
Promotes Healing
Relieves Gum Irritation
Caused by Dentures or Braces

ORAL DEBRIDING AGENT/
ANTISEPTIC RINSE/PAIN RELIEVER

Soothing
MINT

16 FL OZ (473.2 mL)

OJLBF-01904-01 72025286

Principal Display Panel - 473.2 mL Bottle Label
ORAJEL 2X GUM PAIN   ALCOHOL-FREE
menthol and hydrogen peroxide rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-799
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
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Methyl Salicylate (UNII: LAV5U5022Y)  
Phosphoric Acid (UNII: E4GA8884NN)  
Poloxamer 338 (UNII: F75JV2T505)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sorbitol (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-799-16473.2 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/15/2023
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Canada Corp.253933600MANUFACTURE(10237-799)

Revised: 1/2023
Document Id: f5b6af5b-f7fe-4084-b184-965f049ece72
Set id: adf37010-922c-4441-93d6-1e1a95025e90
Version: 1
Effective Time: 20230117
 
Church & Dwight Co., Inc.