FDA.reportPublic FDA data

Crest

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
monthly-update
Hydrated at
2026-06-03 17:51:50

Label at a glance#

ProductCrest Braces Care Cavity Protection
Active ingredientSTANNOUS FLUORIDE
Label structure11 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 6 yrs. of age & 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 supervise children's brushing until good habits are established children under 6 yrs.: ask a dentist

Storage and handling

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 product is specially formulated to help prevent staining see your dentist regularly

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous fluoride 0.454% (0.14% 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

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 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 6 yrs. of age & 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
  • supervise children's brushing until good habits are established
  • children under 6 yrs.: 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
  • this product 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, carrageenan, flavor, sodium citrate, xanthan gum, zinc citrate, sodium hydroxide, stannous chloride, sodium saccharin, sucralose, titanium dioxide, blue 1

Questions?

OTC - QUESTIONS SECTION

1-844-436-7026

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

Crest Braces Care Cavity Protection Toothpaste 99 g carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest

BRACES

CARE

FLUORIDE TOOTHPASTE FOR

ANTICAVITY AND ANTIGINGIVITIS

toothpaste

ANTI-BACTERIAL

DEFENSE*

*fights plaque bacteria associated with gingivitis

FOR PEOPLE WHO

WEAR BRACES

AGES 6+

FRESH MINT

NET WT 4.1 OZ (116 g)

Crest Braces Care Cavity Protection ToothpasteCrest Braces Care Cavity Protection Toothpaste

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN7
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD7
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY7
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY7
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY7

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-879-41CrestBraces Care Cavity Protection116 g in 1 TUBEPASTE, DENTIFRICE1167
69423-879-41CrestBraces Care Cavity Protection1 in 1 CARTONPASTE, DENTIFRICE17
69423-879-46CrestBraces Care Cavity Protection1 in 1 CARTONPASTE, DENTIFRICE17
69423-879-46CrestBraces Care Cavity Protection130 g in 1 TUBEPASTE, DENTIFRICE1307
69423-879-63CrestBraces Care Cavity Protection1 in 1 CARTONPASTE, DENTIFRICE17
69423-879-63CrestBraces Care Cavity Protection178 g in 1 TUBEPASTE, DENTIFRICE1787
69423-879-85CrestBraces Care Cavity Protection1 in 1 CARTONPASTE, DENTIFRICE17
69423-879-85CrestBraces Care Cavity Protection24 g in 1 TUBEPASTE, DENTIFRICE247

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-87969423-879-85, 69423-879-46, 69423-879-63, 69423-879-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCRALOSE96K6UQ3ZD4IACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
SODIUM CITRATE1Q73Q2JULRIACT
ZINC CITRATEK72I3DEX9BIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM GLUCONATER6Q3791S76IACT
CARRAGEENAN5C69YCD2YJIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM HYDROXIDE55X04QC32IIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
STANNOUS FLUORIDE3FTR44B32QACTIM
STANNOUS CHLORIDE1BQV3749L5IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-11-18full-release2026-06-01 01:16:52

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 Braces Care Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd823cba4-c4cf-7d7a-e053-2995a90a01f02026-01-08WarningsExact identifier
ndc (package): 69423-879-63
ndc (package): 69423-879-85
ndc (package): 69423-879-46
ndc (package): 69423-879-41
ndc (product): 69423-879
ndc11 (package): 69423087985
ndc11 (package): 69423087941
ndc11 (package): 69423087963
ndc11 (package): 69423087946
spl id: 47e497ef-68fc-4404-e063-6394a90a0dac
spl set id: d823cba4-c4cf-7d7a-e053-2995a90a01f0

Reported adverse events (FAERS/openFDA)#

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