FDA.reportPublic FDA data

Brush Buddies oral rinse - healthy gums

Manufacturer
Ashtel Studios, Inc.
Effective date
2026-01-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:31:05

Label at a glance#

ProductBrush Buddies oral rinse - healthy gums
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure10 sections

Indications and uses

• Helps reduce Plaque-associated Gingivitis • Helps control gum infections

Dosage and administration

• Adults and children 12 years and older:   Measure 20mL (4 teaspoonfuls) and vigorously swish around the mouth and between teeth for 1 minute and then spit out. Use undiluted twice daily, in the morning and before bedtime. • Children 6 years to under 12 years:   Should be supervised when using this product. • Children under 6 years of age:   Not recommended for use. • Do not swallow.

Storage and handling

• Do not exceed the recommended dosage. • This rinse is not a substitute for brushing or flossing. • Do not use if safety seal is broken or missing.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chloride 0.05%

Purpose

OTC - PURPOSE SECTION

Anti-Gingivitis/Anti-Plaque

Uses

INDICATIONS & USAGE SECTION

• Helps reduce Plaque-associated Gingivitis • Helps control gum infections

Warnings

WARNINGS SECTION

Stop use and ask 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 teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than the rinsing amount is swallowed, seek medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 12 years and older:
  Measure 20mL (4 teaspoonfuls) and vigorously swish around the mouth and between teeth for 1 minute and then spit out. Use undiluted twice daily, in the morning and before bedtime.

• Children 6 years to under 12 years:
  Should be supervised when using this product.

• Children under 6 years of age:
  Not recommended for use.

• Do not swallow.

Other information

STORAGE AND HANDLING SECTION

• Do not exceed the recommended dosage. • This rinse is not a substitute for brushing or flossing.
• Do not use if safety seal is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerine, PEG-40 Hydrogenated castor oil, Sodium benzoate, Citric acid, Flavour, Sucralose, Sodium Chlorite

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

0% alcohol, parabens and triclosan

• cleanses effectively
• gives refreshing feel
• long-lasting freshness
• does not over-dry mouth
• no burning sensation

clean mint

brush buddies satisfaction guaranteed

If you are not satisfied with the product, please call 1 (877) 274-8358 within 30 days of purchase to receive a refund for the purchase price. Retain the original receipt and product UPC

WWW.BRUSHBUDDIES.COM

1-909-434-0911 INTERNATIONAL

COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE
DISTRIBUTED BY: ASHTEL STUDIOS, INC.
ONTARIO, CA 91761, USA

MADE IN INDIA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

oral rinse - healthy gumsoral rinse - healthy gums

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN2
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD2
1251617cetylpyridinium chloride 0.05 % MouthwashSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810147885114GTIN-13: 0810147885114
EAN-13: 0810147885114
GTIN-12: 810147885114
UPC-A: 810147885114
GTIN storage (14 digits): 00810147885114		70108164-2.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-278-01Brush Buddies oral rinse - healthy gums473 mL in 1 BOTTLEMOUTHWASH4732

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-27870108-278-01

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
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM CHLORITEG538EBV4VFIACT

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
Brush Buddies oral rinse - healthy gumsCETYLPYRIDINIUM CHLORIDEAshtel Studios, Inc.b3efe6a0-b232-4f28-a73e-c9c898955d7d2026-01-03WarningsExact identifier
ndc (package): 70108-278-01
ndc (product): 70108-278
ndc11 (package): 70108027801
spl id: 9ee8b460-64c6-4f67-bf47-594d3fd56d5b
spl set id: b3efe6a0-b232-4f28-a73e-c9c898955d7d

Reported adverse events (FAERS/openFDA)#

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