FDA.reportPublic FDA data

Crest Clean Breath Smooth Mint

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:24

Label at a glance#

ProductCrest Clean Breath Smooth Mint
Active ingredientSTANNOUS FLUORIDE
Label structure10 sections

Indications and uses

• aids in the prevention of cavities • helps prevent gingivitis • helps interfere with the harmful effects of plaque associated with gingivitis • helps control plaque bacteria that contribute to the development of gingivitis

Dosage and administration

• adults and children 12 yrs. of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. • do not swallow • children under 12 yrs. of age: ask a dentist

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Stannous fluoride 0.454%

(0.15% w/v fluoride ion)

Purposes

OTC - PURPOSE SECTION

Anticavity, antigingivitis toothpaste

Uses

INDICATIONS & USAGE SECTION

  • • aids in the prevention of cavities • helps prevent gingivitis
    • helps interfere with the harmful effects of plaque associated with
    gingivitis
    • helps control plaque bacteria that contribute to the development of
    gingivitis

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 12 yrs. of age. If more than used
for brushing is accidentally swallowed, get medical help or contact a
Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • • adults and children 12 yrs. of age and older:
    Brush teeth thoroughly, preferably after each meal or at least twice a
    day, or as directed by a dentist or physician.
    • do not swallow
    • children under 12 yrs. of age: ask a dentist

Other information

WARNINGS AND PRECAUTIONS SECTION

  • products containing stannous fluoride may produce surface staining of the teeth
  • adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
  • this Crest is specially formulated to help prevent staining
  • see your dentist regularly

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol,
hydrated silica, sodium lauryl sulfate, sodium
gluconate, flavor, carrageenan, sodium citrate,
xanthan gum, zinc citrate, sodium hydroxide,
stannous chloride, sodium saccharin, sucralose,
Other information mica, titanium dioxide, blue 1

Questions?

OTC - QUESTIONS SECTION

1-800-594-4158

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

Principal Display Panel - 3 93 g tube in carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE 3 PACK

+ WHITENING

Crest

Doesn't just mask,

neutralizes bad breath

CLEAN

BREATH

FLUORIDE TOOTHPASTE

FOR ANTICAVITY AND ANTIGINGIVITIS

SMOOTH MINT

3-3.3 OZ (93 g) TUBES EACH;

TOTAL NET WT 9.9 OZ (280 g)

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN1
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD1
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY1
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY1
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-643-03CrestClean Breath Smooth Mint93 g in 1 TUBEPASTE, DENTIFRICE931
84126-643-03CrestClean Breath Smooth Mint3 in 1 CARTONPASTE, DENTIFRICE31

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-64384126-643-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
STANNOUS CHLORIDE1BQV3749L5IACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
CARRAGEENAN5C69YCD2YJIACT
SODIUM GLUCONATER6Q3791S76IACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITOL506T60A25RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BLUE 1H3R47K3TBDIACT
ZINC CITRATEK72I3DEX9BIACT
MICAV8A1AW0880IACT
STANNOUS FLUORIDE3FTR44B32QACTIM

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
Crest Clean Breath Smooth MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f2042b4-8eae-5c2c-e063-6394a90a640c2026-04-10WarningsExact identifier
ndc (package): 84126-643-03
ndc (product): 84126-643
ndc11 (package): 84126064303
spl id: 4f2054af-bc20-2896-e063-6394a90a2bc9
spl set id: 4f2042b4-8eae-5c2c-e063-6394a90a640c

Reported adverse events (FAERS/openFDA)#

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