ORAJLE ANTI-BACTERIAL RINSE FOR BLEEDING GUMS - cetylpyridinium chloride 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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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

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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE.001 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
PHOSPHATE ION (UNII: NK08V8K8HR)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Accupac, Inc.071609663manufacture

Revised: 7/2010
Document Id: 2f044f4a-9999-4b27-b7e7-645d4627ff3c
Set id: 48b1f5b8-69b1-4d50-960b-733151beef91
Version: 1
Effective Time: 20100730
 
Church & Dwight Co., Inc.