MOUTHWASH- cetylpyridinium chloride rinse 
Yuyao Jessie Commodity Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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51414-105 Mouthwash

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

4

MOUTHWASH 
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51414-105
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.07 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51414-105-0110 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/2016
2NDC:51414-105-0212 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/2016
3NDC:51414-105-0320 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/2016
4NDC:51414-105-0430 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/2016
5NDC:51414-105-0540 g in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
6NDC:51414-105-0650 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/2016
7NDC:51414-105-0760 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/2016
8NDC:51414-105-0870 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/2016
9NDC:51414-105-0980 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/2016
10NDC:51414-105-1090 g in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
11NDC:51414-105-11100 g in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
12NDC:51414-105-12120 g in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
13NDC:51414-105-13250 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/2016
14NDC:51414-105-14350 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/2016
15NDC:51414-105-15420 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/2016
16NDC:51414-105-16450 g in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
17NDC:51414-105-17500 g in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
18NDC:51414-105-18600 g in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/10/2016
Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)
Establishment
NameAddressID/FEIBusiness Operations
Yuyao Jessie Commodity Co.,Ltd.529892305manufacture(51414-105)

Revised: 12/2022
 
Yuyao Jessie Commodity Co.,Ltd.