Medication Guide App

Orajle Anti-Bacterial Rinse for Bleeding Gums

Dosage form: liquid
Ingredients: CETYLPYRIDINIUM CHLORIDE .001mL in 1mL
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-721

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 

Cetylpyridinium chloride 0.1%   Antigingivitis/Antiplaque

Uses
helps prevent plaque that leads to
gingivitis
bleeding gums

Warnings

When using this product do not swallow
Stop use and ask a dentist if
  • gingivitis, bleeding or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth.  These may be signs or symptoms of periodontitis, a serious form of gum disease.
Keep out of reach of children under 6 years of age.  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.



Adults and children                     Vigorously swish 20 milliliters of rinse between your teeth
6 years of age and older              twice a day for 30 seconds and then spit out. Do not swallow the rinse

Children 6 years to under            Supervise use
12 years of age  

Children under 6 years of age      Do not use



Other information this rinse is not intended to replace brushing or flossing ; cap tightly; keep away from heat or direct sunlight; do not use if safety seal is broken or missing.

Inactive ingredients alcohol (14.2% by volume), disodium phosphate, flavor, green 5, poloxamer 407, purified water, sodium phosphate, sodium saccharin, sorbitol, yellow 5

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

for Bleeding Gums 16 oz.

Label image



ORAJLE ANTI-BACTERIAL RINSE FOR BLEEDING GUMS 
cetylpyridinium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-721
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE.001 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
PHOSPHATE ION 
D&C GREEN NO. 5 
POLOXAMER 407 
WATER 
SODIUM PHOSPHATE  
SACCHARIN SODIUM 
SORBITOL 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:10237-721-16473.2 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/30/2010
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Accupac, Inc.071609663manufacture

Revised: 07/2010
 
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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