Crest

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-05-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:31:09

Label at a glance#

ProductCrest Sensi-Care
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

Adults and children 6 years & older: Use twice a day after brushing your teeth with a toothpaste. Vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.022% (0.01% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years & older:

Use twice a day after brushing your teeth with a toothpaste.

  • Vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out.
  • Do not swallow the rinse.
  • Do not eat or drink for 30 minutes after rinsing.
  • Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • Children under 6 years of age: Consult a dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, flavor, poloxamer 407, cetylpyridinium chloride, sodium saccharin, phosphoric acid, methylparaben, sucralose, propylparaben, disodium phosphate, yellow 6, green 3

Questions?

OTC - QUESTIONS SECTION

1–800–285–9139

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HELPS YOU GET
BETTER DENTAL
CHECK-UPS†

Crest ®
ANTICAVITY FLUORIDE RINSE

SENSI • CARE™
WITH FLUORIDE - ALCOHOL FREE
FORMULA‡

  • STRENGTHENS ENAMEL
    WEAKENED BY ACIDS**
  • HELPS PREVENT CAVITIES
  • CLEANS TEETH & GUMS
  • FRESHENS BREATH
  • NO BURN OF ALCOHOL

MILD MINT

IMPORTANT: Read directions for proper use.

‡DOES NOT RELIEVE OR TREAT SENSITIVE
TEETH, ORAL PAIN OR GUM DISEASE

500 mL (16.9 FL OZ)

96677460

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W71
Fluoride IonACTIVE MOIETYQ80VPU408O1
cetylpyridinium chlorideINACTIVE INGREDIENTD9OM4SK49P1
fd&c green no. 3INACTIVE INGREDIENT3P3ONR6O1S1
fd&c yellow no. 6INACTIVE INGREDIENTH77VEI93A81
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
methylparabenINACTIVE INGREDIENTA2I8C7HI9T1
phosphoric acidINACTIVE INGREDIENTE4GA8884NN1
poloxamer 407INACTIVE INGREDIENTTUF2IVW3M21
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TY1
sodium phosphate, dibasic, anhydrousINACTIVE INGREDIENT22ADO53M6F1
sucraloseINACTIVE INGREDIENT96K6UQ3ZD41
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-85837000-858-01, 37000-858-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 423 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
fd&c yellow no. 6FD&C YELLOW NO. 6H77VEI93A8FILM / SUBLINGUAL0.03 mgExact identifier — unii candidate
34 equally ranked IID candidates
sodium phosphate, dibasic, anhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCAPSULE / ORAL40 mgExact identifier — unii candidate
48 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
fd&c yellow no. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, COATED / ORAL3.17 mgExact identifier — unii candidate
34 equally ranked IID candidates
sodium phosphate, dibasic, anhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / SUBCUTANEOUS0.11 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
fd&c yellow no. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii candidate
34 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / NASAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii candidate
79 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
poloxamer 407POLOXAMER 407TUF2IVW3M2GEL / PERIODONTAL155 mgExact identifier — unii candidate
15 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
poloxamer 407POLOXAMER 407TUF2IVW3M2GEL / TOPICAL28 mgExact identifier — unii candidate
15 equally ranked IID candidates
fd&c yellow no. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNCREAM / VAGINAL0.56 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
fd&c yellow no. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
34 equally ranked IID candidates
fd&c yellow no. 6FD&C YELLOW NO. 6H77VEI93A8SOAP / TOPICAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNPASTE, DENTIFRICE / DENTALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
68 equally ranked IID candidates
cetylpyridinium chlorideCETYLPYRIDINIUM CHLORIDED9OM4SK49PAEROSOL, SPRAY / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
5 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
fd&c yellow no. 6FD&C YELLOW NO. 6H77VEI93A8GEL / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SPRAY / NASAL2 mgExact identifier — unii candidate
22 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TGRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii candidate
68 equally ranked IID candidates
poloxamer 407POLOXAMER 407TUF2IVW3M2SUSPENSION / ORAL10 mgExact identifier — unii candidate
15 equally ranked IID candidates
cetylpyridinium chlorideCETYLPYRIDINIUM CHLORIDED9OM4SK49PAEROSOL, METERED / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
5 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii candidate
22 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TPOWDER / ORALNAExact identifier — unii candidate
79 equally ranked IID candidates
sodium phosphate, dibasic, anhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR139.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
sodium phosphate, dibasic, anhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRA-ARTICULAR28 mgExact identifier — unii candidate
48 equally ranked IID candidates
fd&c green no. 3FD&C GREEN NO. 33P3ONR6O1SSOLUTION / TOPICALNAExact identifier — unii candidate
15 equally ranked IID candidates
fd&c yellow no. 6FD&C YELLOW NO. 6H77VEI93A8SUSPENSION / ORAL11 mgExact identifier — unii candidate
34 equally ranked IID candidates
fd&c yellow no. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE / ORAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii candidate
79 equally ranked IID candidates
sodium phosphate, dibasic, anhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCAPSULE, EXTENDED RELEASE / ORAL207 mgExact identifier — unii candidate
48 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
sodium phosphate, dibasic, anhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSPRAY / NASAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SUSPENSION / ORAL85 mgExact identifier — unii candidate
34 equally ranked IID candidates
poloxamer 407POLOXAMER 407TUF2IVW3M2SOLUTION / ORAL50 mg/5mlExact identifier — unii candidate
15 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii candidate
22 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
fd&c yellow no. 6FD&C YELLOW NO. 6H77VEI93A8MOUTHWASH / BUCCAL0.01 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR0.4 mgExact identifier — unii candidate
68 equally ranked IID candidates
fd&c yellow no. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii candidate
34 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYGRANULE, FOR SOLUTION / ORAL5.5 mg/120mlExact identifier — unii candidate
34 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHFILM, SOLUBLE / BUCCAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
sodium phosphate, dibasic, anhydrousSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSUSPENSION / ORAL66 mgExact identifier — unii candidate
48 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRALESIONAL0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAVENOUS6 mgExact identifier — unii candidate
68 equally ranked IID candidates

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
07731588-f7f7-f59f-e063-6394a90a992c8ef82ff8-b2d0-4365-86d7-8c6598c9a3ca2023-10-11WarningsExact identifier
spl set id: 8ef82ff8-b2d0-4365-86d7-8c6598c9a3ca

Reported adverse events (FAERS/openFDA)#

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