Mouthwash

Manufacturer
Yuyao Jessie Commodity Co.,Ltd.
Effective date
2022-12-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:44:05

Label at a glance#

ProductMouthwash
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure6 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium chloride 0.07%

Purpose

OTC - PURPOSE SECTION

Antigingivitis/Antiplaque

Use

INDICATIONS & USAGE SECTION

helps control plaque that leads to gingivitis and bleeding gums

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51414-105-012022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-022022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-032022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-042022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-052022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-062022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-072022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-082022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-092022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-102022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-112022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-122022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-132022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-142022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-152022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-162022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-172022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-182022-12-17C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-012022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-022022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-032022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-042022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-052022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-062022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-072022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-082022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-092022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-102022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-112022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-122022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-132022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-142022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-152022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-162022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-172022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash
51414-105-182022-01-28C16284748780-1d6a99b39-4eae-a426-e053-dadaa90af4c251414-105 Mouthwash

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f0036d99-1936-1b61-e053-2995a90aaff84349fb6e-cf56-544c-e054-00144ff8d46c2022-12-17WarningsExact identifier
spl id: f0036d99-1936-1b61-e053-2995a90aaff8
spl set id: 4349fb6e-cf56-544c-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.