Other
Drug Facts
DISTRIBUTED BY:
FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
For product questions or concerns, contact us at 1-877-849-9949
Care One Restore And Defend Paste, Dentifrice
FDA Label NDC 41520-722
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foodhold U.s.a. for the product Care One Restore And Defend (NDC 41520-722). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Stannous Fluoride 0.454% w/w (0.15% fluoride ion)
Otc - Purpose
Purpose
Anticavity/Antihypersensitivity
Indications & Usage
Uses
- aids in the prevention of dental cavities
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
Warnings
Warnings
Otc - When Using
When using this product, if irritation occurs discontinue use.
Otc - Stop Use
Stop use and ask a dentist if:
- the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
- pain/sensitivity still persists after 4 weeks of use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than used for brushing is accidentally swallowed get medical help or contact a poison control center right away.
Dosage & Administration
Directions
Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
- Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as directed by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
- Do not swallow
- Children under 12 years of age: consult a dentist or doctor
Storage And Handling
Other information
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 specifically formulated to help prevent staining.
- store below 30°C (86°F)
Inactive Ingredient
Inactive ingredients glycerin, water, hydrated silica, pentasodium triphosphate, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin
Otc - Questions
Questions or Comments? CALL 1-877-846-9949
Package Label.Principal Display Panel
CareOne®
RESTORE & DEFEND SENSITIVE TOOTHPASTE
FOR SENSITIVE TEETH & CAVITY PROTECTION
DAILY PROTECTION FOR SENSITIVE TEETH
WHITENING
FRESH MINT
NET WT 3.4 OZ (96.3 g)
Careone_restoredefend_carton_2821293r1 (Careone Restoredefend Carton 2821293r1)
* Please review the disclaimer below.
