MOUTHWASH- cetylpyridinium chloride rinse

Mouthwash by

Drug Labeling and Warnings

Mouthwash by is a Otc medication manufactured, distributed, or labeled by Yuyao Jessie Commodity Co.,Ltd.. 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 and bleeding gums

WARNINGS

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 if swallowed,get medical help to contact a poison control center reght away

Keep out of reach of children under 16 years of age.

If more than used for rinsing is accidentally swallowed, get

medical help or contact a Poison Control Center right away.

Directions

use after your normal brushing and flossing routine; rinse

toothpaste from mouth prior to use

adults & older: Rinse for 30 seconds with 20 mL(4 teaspoonfuls)

twice a day

do not swallow

children under 16 years of age: do not use

Inactive ingredients

Blue 1, Cetrimonium Chloride, Citric Acid, Flavor, Glycerin, Poloxamer 407, Sodium Benzoate, Sodium Saccharin, Water, Xylitol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MOUTHWASH 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51414-105
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.07 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
EDETIC ACID (UNII: 9G34HU7RV0)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51414-105-01	10 g in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2016
2	NDC: 51414-105-02	12 g in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2016
3	NDC: 51414-105-03	20 g in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2016
4	NDC: 51414-105-04	30 g in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2016
5	NDC: 51414-105-05	40 g in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2016
6	NDC: 51414-105-06	50 g in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2016
7	NDC: 51414-105-07	60 g in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2016
8	NDC: 51414-105-08	70 g in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2016
9	NDC: 51414-105-09	80 g in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2016
10	NDC: 51414-105-10	90 g in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2016
11	NDC: 51414-105-11	100 g in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2016
12	NDC: 51414-105-12	120 g in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2016
13	NDC: 51414-105-13	250 g in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2016
14	NDC: 51414-105-14	350 g in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2016
15	NDC: 51414-105-15	420 g in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2016
16	NDC: 51414-105-16	450 g in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2016
17	NDC: 51414-105-17	500 g in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2016
18	NDC: 51414-105-18	600 g in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/10/2016

Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)

Establishment
Name	Address	ID/FEI	Business Operations
Yuyao Jessie Commodity Co.,Ltd.		529892305	manufacture(51414-105)