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Orajel Antiseptic Rinse For All Mouth Sores

Medically reviewed on October 23, 2017

Dosage form: liquid
Ingredients: HYDROGEN PEROXIDE 1.5mL in 1mL, MENTHOL 1mg in 1mL
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-760

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.

DRUG FACTS Orajel Antiseptic Rinse for All Mouth Sores

Active ingredient

Hydrogen peroxide 1.5%

Menthol 0.1%

Purpose

Oral debriding agent/Oral antiseptic

Oral pain reliever

Uses

  • first aid to help reduce bacteria in minor oral wounds
  • for temporary pain relief and
  • use in cleansing minor wounds or minor gum inflammation resulting from:
  • minor dental procedures
  • accidental injury
  • orthodontic appliances
  • canker sores
  • dentures
  • other irritations of the mouth and gums

Aids in the removal of

  • phlegm
  • mucus
  • other secretions associated with occasional sore mouth

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
  • irritations, 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

  • remove imprinted safety seal from bottle cap
  • to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed.

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

  • cap tightly
  • keep away from heat or direct sunlight
  • do not use if safety seal is broken or missing

Inactive ingredients 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

Orajel Alcohol Free Antiseptic Rinse

#1

PAIN RELIEVER

BRAND FOR ADULTS

NOW WITH PAIN RELIEF!

Orajel

Antiseptic Rinse

FOR ALL MOUTH SORES

Canker Sores Cheek Bites Gum Irritation

Irritatrion from Dentures or Braces

Promotes Healing

Kills Bacteria

Provides Pain Relief

FRESH MINT

ORAL DEBRIDING AGENT / ANTISEPTIC RINSE / PAIN RELIEVER

16 FL OZ (473.2 mL)

Front Label OJLBF-32499-04.jpg

Back Label OJLBB-32499-04.jpg

ORAJEL ANTISEPTIC RINSE  FOR ALL MOUTH SORES
hydrogen peroxide 1.5%, menthol 0.1% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-760
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE1.5 mL  in 1 mL
MENTHOL (MENTHOL) MENTHOL1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
EDETATE DISODIUM 
METHYL SALICYLATE 
PHOSPHORIC ACID 
POLOXAMER 338 
POLYSORBATE 20 
SACCHARIN SODIUM 
SORBITOL 
WATER 
ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:10237-760-16473.2 mL in 1 BOTTLE
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/FEIOperations
Church & Dwight Canada Corp.253933600manufacture(10237-760)

 
Church & Dwight Co., Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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