FDA.reportPublic FDA data

FreshMax Mouthwash

Manufacturer
BRANDS INTERNATIONAL
Effective date
2023-03-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:34:08

Label at a glance#

ProductFreshMax Mouthwash Fresh Mint Flavor
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure9 sections

Indications and uses

help control plaque that leads to gingivitis

Dosage and administration

Adults and children 12 years of age and older: spray into mouth where irritation is present 1 to 3 times, or spray and swish the liquid to affected areas. Expectorate any residual liquid. Use up to 3 times a day, or as directed by a dentist or doctor. Children under 12 years of age: consult a dentist or physician.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Cetylpridinium Chloride 0.07%

Purpose

OTC - PURPOSE SECTION

Antigingivitis, Antiplaque

Uses

INDICATIONS & USAGE SECTION

help control plaque that leads to gingivitis

Warnings

WARNINGS SECTION

  • 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
  • If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older: spray into mouth where irritation is present 1 to 3 times, or spray and swish the liquid to affected areas. Expectorate any residual liquid. Use up to 3 times a day, or as directed by a dentist or doctor.
  • Children under 12 years of age: consult a dentist or physician.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 Contol Center right away.

Other Information

OTHER SAFETY INFORMATION

this rinse is not intended to replace brushing or flossing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, flavor, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-33450157-334-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
BENZOIC ACID8SKN0B0MIMIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB

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
08a0d254-b3e5-6abb-e063-6394a90ab84af785c9ac-064f-7864-e053-6294a90a46f42023-10-26WarningsExact identifier
spl set id: f785c9ac-064f-7864-e053-6294a90a46f4

Reported adverse events (FAERS/openFDA)#

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