ORAJLE ANTI-BACTERIAL RINSE FOR BLEEDING GUMS- cetylpyridinium chloride liquid

Orajle Anti-Bacterial Rinse for Bleeding Gums by

Drug Labeling and Warnings

Orajle Anti-Bacterial Rinse for Bleeding Gums by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., Accupac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Orajel Anti-Bacterial Rinse

for Bleeding Gums 16 oz.

Label image

INGREDIENTS AND APPEARANCE

ORAJLE ANTI-BACTERIAL RINSE FOR BLEEDING GUMS 
cetylpyridinium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-721
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	.001 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-721-16	473.2 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/30/2010

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	manufacture