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Orajel Antiseptic Rinse for Mouth Sores

Medically reviewed on July 31, 2017

Dosage form: liquid
Ingredients: hydrogen peroxide .015mL in 1mL
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-720

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

Active ingredient                 Purpose

hydrogen peroxide 1.5%      Oral debriding agent

Uses for temporary use in cleansing minor wounds or minor gum inflammation resulting form:
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 doctor

When using this product do not swallow

Stop use and see your dentist or doctor 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. in case of overdose or allergic reaction, 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                       Swish one-half capful (2teaspoons - 10mL) around the    
2 years of age and older                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 doctor

Children under 12 year of age        Should be supervised in the use of this product 

Children under 2 years of age        Consult a dentist or doctor        



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, methylparaben, methyl salicylate, phosphoric acid, poloxamer 338, purified water, sodium saccharin, sorbitol

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

Orajel Anti-Bacterial Rinse

fro Bleeding Gums

Label image

ORAJEL ANTISEPTIC RINSE FOR MOUTH SORES 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-720
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
hydrogen peroxide (hydrogen peroxide) hydrogen peroxide.015 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
FD&C BLUE NO. 1 
EDETATE DISODIUM 
METHYLPARABEN 
METHYL SALICYLATE 
PHOSPHORIC ACID 
SORBITOL 
WATER 
SACCHARIN SODIUM 
Packaging
#Item CodePackage Description
1NDC:10237-720-16473.2 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/29/2010
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Accupac, Inc.071609663manufacture

 
Church & Dwight Co., Inc.

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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