FDA.reportPublic FDA data

Whitening Kit

Manufacturer
CVS | Lornamead
Effective date
2025-01-24
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:41:53

Label at a glance#

ProductWhitening Kit
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

OTC - PURPOSE SECTION

Anticavity

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or doctor. * instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). * supervise children as necessary until capable of using without supervision. * children under 2 years of age: consult a dentist or doctor.

INACTIVE INGREDIENT SECTION

glycerin, hydrated silica, water, sorbitol, pentasodium triphosphate, PVP, titanium dioxide, cellulose gum, flavor, cocamidopropyl betaine, sodium lauryl sulfate, potassium sorbate, sorbic acid, potassium acesulfame, sucralose, sodium hydroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kit R1Kit R1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51316-410-092024-02-12C16284748780-1f386c649-e9b0-0266-e053-dadaa90a7c1a5820410 CVS Weekend White Kit
51316-410-092023-01-30C16284748780-1f386c649-e9b0-0266-e053-dadaa90a7c1a5820410 CVS Weekend White Kit

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-41051316-410-09
51316-411

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
POVIDONEFZ989GH94EIACT
SORBITOL506T60A25RIACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBIC ACIDX045WJ989BIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SUCRALOSE96K6UQ3ZD4IACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
HYDRATED SILICAY6O7T4G8P9IACT

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
47e567bf-e6e3-d848-e063-6294a90aaa40d0700749-8f6b-70a0-e053-2a95a90af5402026-01-08WarningsExact identifier
spl set id: d0700749-8f6b-70a0-e053-2a95a90af540

Reported adverse events (FAERS/openFDA)#

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