FDA.reportPublic FDA data

Crest Gum Detoxify

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
monthly-update
Hydrated at
2026-06-03 17:52:16

Label at a glance#

ProductCrest Gum Detoxify plus Whitening
Active ingredientSTANNOUS FLUORIDE
Label structure8 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Warning

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

STORAGE AND HANDLING 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
  • see your dentist regularly

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrated silica, water, zinc lactate, sodium lauryl sulfate, trisodium phosphate, flavor, sodium gluconate, sodium saccharin, xanthan gum, cellulose gum, sodium hydroxide, polyethylene, mica, titanium dioxide, blue 1

Questions?

OTC - QUESTIONS SECTION

(800) 492-7378

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINICALLY PROVEN RESULTS IN ONE WEEK

Crest®
GUM DETOXIFY

+ WHITENING™

FLUORIDE TOOTHPASTE FOR ANTICAVITY AND

ANTIGINGIVITIS/WHITENING GEL

STEP 1

6X Gum health
Improvement in one week*
*gingivitis improvement vs. ordinary toothpaste

STEP 2

Whiter teeth
in 1 week**
**improvement vs. ordinary toothpaste

1 TUBE NET WT 4.0 OZ (113 g) & 1 TUBE NET WT 2.3 OZ (65 g)

489489

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN10
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD10
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY10
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY10
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY10

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-489-01Crest Gum Detoxifyplus Whitening1 in 1 CARTONKIT110

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-48937000-489-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
ZINC LACTATE2GXR25858YIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM GLUCONATER6Q3791S76IACT
GLYCERINPDC6A3C0OXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM HYDROXIDE55X04QC32IIACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
STANNOUS FLUORIDE3FTR44B32QACTIM
WATER059QF0KO0RINGR
GLYCERINPDC6A3C0OXINGR
HYDROGEN PEROXIDEBBX060AN9VINGR
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDINGR
SUCRALOSE96K6UQ3ZD4INGR
SODIUM HYDROXIDE55X04QC32IINGR
CARBOXYPOLYMETHYLENE0A5MM307FCINGR

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-08-06full-release2026-06-01 01:09:40

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 Gum Detoxify plus WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company63779942-0f6c-11c5-e053-2991aa0a25ab2026-01-08WarningsExact identifier
ndc (package): 37000-489-01
ndc (product): 37000-489
ndc11 (package): 37000048901
spl id: 47e4dc98-55f0-efbb-e063-6294a90a7f84
spl set id: 63779942-0f6c-11c5-e053-2991aa0a25ab

Reported adverse events (FAERS/openFDA)#

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