ANTIGINGIVITIS/ANTIPLAQUE- cetylpyridinium chloride mouthwash

Antigingivitis/Antiplaque by

Drug Labeling and Warnings

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

Drug Details [pdf]

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Disclaimer

QUALITY GUARANTEED

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

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

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

Questions?

Call 1-888-423-0139

Adverse reaction

DISTRIBUTED BY TOPCO ASSOCIATED LLC, ITASCA, IL 60143

©TOPCO VIJA1123    QUESTIONS? 1-888-423-0139

topcare@topco.com    www.topcarebrand.com

Scan here for more information or call 1-888-423-0139

Principal Display Panel

COMPARE TO CREST ® PRO-HEALTH ® ORAL RINSE GUM AND BREATH PURIFY*

TopCare ® everyday

ALCOHOL FREE

Gum Defense

Antigingivitis/Antiplaque

Oral Rinse

SMOOTH MINT

• Helps improve gum hygiene
• CPC antigingivitis/antiplaque oral rinse
• kills germs that cause bad breath
• helps defend against early signs of gum disease

IMPORTANT: Read directions for proper use.

1 L (1 QT 1.8 FL OZ) 33.8 FL OZ

INGREDIENTS AND APPEARANCE

ANTIGINGIVITIS/ANTIPLAQUE 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-090
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
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
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: 76162-090-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M505G(a)(3)	04/05/2024

Labeler - Topco Associates LLC (006935977)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(76162-090)