FDA.reportPublic FDA data

ACTIVE INGREDIENTS

Manufacturer
GreenMark Biomedical Inc.
Effective date
2026-09-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-16 01:00:57

Label at a glance#

ProductCrystLCare Regeneration Plus
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure10 sections

Indications and uses

Aids in the prevention of dental caries (cavities) Builds protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Dosage and administration

adults and children 6 years of age and older: Use once a day after brushing teeth with toothpaste followed by rinsing with water. Apply dental strip onto the teeth. Allow to remain on the teeth for 3 min and then spit out residue. Do not eat or drink for 30 minutes. Instruct children under 12 years of age in the use of this product. Supervise children as necessary until capable of using without supervision. childr...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Potassium Nitrate 5%

Sodium Fluoride 0.05%

PURPOSE

OTC - PURPOSE SECTION

Antisensitivity

Anticavity

USES

INDICATIONS & USAGE SECTION

Aids in the prevention of dental caries (cavities)

Builds protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

WARNINGS

WARNINGS SECTION

For topical intraoral use only.

Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product for more than 4 weeks unless recommended by a dentist or doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for daily application is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years of age and older: Use once a day after brushing teeth with toothpaste followed by rinsing with water. Apply dental strip onto the teeth. Allow to remain on the teeth for 3 min and then spit out residue. Do not eat or drink for 30 minutes. Instruct children under 12 years of age in the use of this product. Supervise children as necessary until capable of using without supervision.

children under the age of 6: Consult a dentist.

INACTIVE INGREDIENT SECTION

Calcium/phosphate loaded starch particle (contains Calcium, Phosphate, Starch), natural peppermint oil, pullulan, stevia, vegetable glycerin, water.

QUESTIONS

OTC - QUESTIONS SECTION

1-810-899-0710

PRINCIPAL DISPLAY PANEL - 14 POUCH CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CrystLCare REGENERATION +

14 ANTICAVITY & ANTISENSITIVITY DISSOLVABLE DENTAL STRIPS

Potassium Nitrate 5% - Sodium Fluoride 0.05%

IMPORTANT: Read directions for proper use

Peel – Apply – Heal – Protect

POWERED by Dentulu

Rx ONLY

CrystLCare REGENERATION Principal Display PanelCrystLCare REGENERATION Principal Display Panel

PACKAGE LABEL - 14 POUCH CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OUTER PACKAGING - COMPLETE CARTON LABEL

CrystLCare REGENERATION Outer PackagingCrystLCare REGENERATION Outer Packaging

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87587-25087587-250-50, 87587-250-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
PULLULAN8ZQ0AYU1TTIACT
GLYCERINPDC6A3C0OXIACT
STEVIA REBAUDIANA WHOLE6U422Y08O2IACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
CALCIUMSY7Q814VUPIACT
PHOSPHATE IONNK08V8K8HRIACT
STARCH, CORNO8232NY3SJIACT

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
CrystLCare Regeneration PlusPOTASSIUM NITRATE, SODIUM FLUORIDEGreenMark Biomedical Inc.4f86d0a0-d73e-5605-e063-6394a90adb382026-09-14WarningsExact identifier
ndc (package): 87587-250-50
ndc (package): 87587-250-01
ndc (product): 87587-250
ndc11 (package): 87587025001
ndc11 (package): 87587025050
spl id: 4f86d0a0-d73f-5605-e063-6394a90adb38
spl set id: 4f86d0a0-d73e-5605-e063-6394a90adb38

Reported adverse events (FAERS/openFDA)#

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