Active Ingredients
Potassium Nitrate 5%
Sodium Fluoride 0.05%
Crystlcare Regeneration Plus Film, Soluble
FDA Label NDC 87587-250
10 label sections · Submitted to the FDA by Greenmark Biomedical Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Greenmark Biomedical Inc. for the product Crystlcare Regeneration Plus (NDC 87587-250). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredient section, questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antisensitivity
Anticavity
Uses
Aids in the prevention of dental caries (cavities)
Builds protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
Warnings
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
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
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
1-810-899-0710
Principal Display Panel - 14 Pouch Carton
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
Package Label - 14 Pouch Carton
OUTER PACKAGING - COMPLETE CARTON LABEL
Crystlcare Regeneration Outer Packaging (Crystlcare Ccrp 420 01 Unit Pack 01)
* Please review the disclaimer below.
