ANTIGINGIVITIS/ANTIPLAQUE- cetylpyridinium chloride mouthwash

Antigingivitis/Antiplaque by

Drug Labeling and Warnings

Antigingivitis/Antiplaque by is a Otc medication manufactured, distributed, or labeled by Nice-Pak Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Cetylpyridinium Chloride 0.07%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

For this product

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 increased 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

• adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
• do not swallow
• children 6 years to under 12 years of age: supervise use
• when used after brushing, rinse mouth with water first
• children under 6 years of age: do not use

Other information

• this rinse is not intended to replace brushing or flossing

Inactive ingredients

water, glycerin, flavor, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, cinnamal, blue 1

Disclaimer

This may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ® Pro-Health ® CPC Antiginigivitis/Antiplaque Oral Rinse Gum and Breath Purify Smooth Mint.

Tamper evident statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Adverse reaction

Distributed by:

Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

Principal display panel

SWAN ®

COMPARE TO Crest ® Pro Health ®*

$1.25

GUM DEFENSE

MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE

SMOOTH MINT

• Helps reduce early signs of gum disease
• Kills the germs that cause bad breath
• Alcohol free

500 mL (1.05 PT) 16.9 FL OZ

INGREDIENTS AND APPEARANCE

ANTIGINGIVITIS/ANTIPLAQUE 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-900
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ZINC LACTATE (UNII: 2GXR25858Y)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLOXAMER 407 (UNII: TUF2IVW3M2)
CINNAMALDEHYDE (UNII: SR60A3XG0F)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-900-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	05/01/2024

Labeler - Nice-Pak Products, LLC (119091520)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(11344-900)