MULTI-ACTION ANTISEPTIC- cetylpyridinium chloride rinse

Multi-Action Antiseptic by

Drug Labeling and Warnings

Multi-Action Antiseptic by is a Otc medication manufactured, distributed, or labeled by American Sales Company, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TEP

Sealed With Printed Neckband For Your Protection

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, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Disclaimer

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

*This product is not manufactured or distributed by Proctor & Gamble, distributer of Crest Pro-Health Multi-Protection Alcohol Free Rinse - Refreshing Clean Mint

ADVERSE REACTION

DISTRIBUTED BY:

Foodhold U.S.A., LLC

Landover, MD 20785

1-877-846-9949

(c) 2018 S&S Brands, LLC

Quality guaranteed or your money back

principal display panel

CAREONE

*Compare to Crest Pro Health Clean Mint*

MULTI-ACTION

ANTISEPTIC ORAL RINSE

ANTIGINGIVITIS/ANTIPLAQUE

KILLS GERMS

ALCOHOL-FREE

VIVID MINT FLAVOR

HELPS PREVENT PLAQUE

HELPS PREVENT GINGIVITIIS 

FRESHENS BREATH

33.8 FL OZ (1.05 QT) 1 L

INGREDIENTS AND APPEARANCE

MULTI-ACTION ANTISEPTIC 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-299
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)
POLOXAMER 188 (UNII: LQA7B6G8JG)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-299-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/25/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	04/25/2018

Labeler - American Sales Company (809183973)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(41520-299)