FreshMax Mouthwash by BRANDS INTERNATIONAL / Brands International FreshMax Mouthwash

FreshMax Mouthwash by

Drug Labeling and Warnings

FreshMax Mouthwash by is a Otc medication manufactured, distributed, or labeled by BRANDS INTERNATIONAL, Brands International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FRESHMAX MOUTHWASH FRESH MINT FLAVOR- cetylpridinium chloride solution 
BRANDS INTERNATIONAL

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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FreshMax Mouthwash

Active ingredients

Cetylpridinium Chloride 0.07%

Purpose

Antigingivitis, Antiplaque

Uses

help control plaque that leads to gingivitis

Warnings

• 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

• 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

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

this rinse is not intended to replace brushing or flossing.

Inactive ingredients

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

Label

FRESHMAX MOUTHWASH  FRESH MINT FLAVOR
cetylpridinium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50157-334
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50157-334-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/22/2010	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/22/2010	01/01/2017

Labeler - BRANDS INTERNATIONAL (243748238)

Establishment
Name	Address	ID/FEI	Business Operations
Brands International		243748238	manufacture(50157-334)

Revised: 10/2023

Document Id: 08a0d254-b3e5-6abb-e063-6394a90ab84a

34390-5

Set id: f785c9ac-064f-7864-e053-6294a90a46f4

Version: 3

Effective Time: 20231026