ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES- hydrogen peroxide and 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 Rinse for All Mouth Sores

Hydrogen peroxide 1.5%

Menthol 0.1%

Oral debriding agent/Oral antiseptic

Oral pain reliever

Aids in the removal of:

When using this product do not swallow

do not exceed recommended dosage

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

Stop use and see your physician promptly if swallowing, 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 older

Swish one-half capful (2 tesapoons=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

alcohol (4.1% by volume), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

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

#1

ORAL PAIN

RELIEVER BRAND

FOR ADULTS

With

PAIN RELIEF!

Orajel™

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

ORAL DEBRIDING AGENT / ANTISEPTIC RINSE / PAIN RELIEVER

16 FL OZ (473.2 mL)

DA2011184_OJLBF-32499-06_72013522

10237-793 Back Label

ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES 
hydrogen peroxide and menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-760
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
POLOXAMER 338 (UNII: F75JV2T505)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-760-16473.2 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2014
2NDC:10237-760-481419.5 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35611/01/2014
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Canada Corp.253933600MANUFACTURE(10237-760)

Revised: 1/2023
Document Id: 3c5c04cc-5c3e-4a6f-b1ea-1389afd57bd6
Set id: 06188d36-0d60-6ae6-e054-00144ff8d46c
Version: 3
Effective Time: 20230110
 
Church & Dwight Co., Inc.