CARE ONE RESTORE AND DEFEND SENSITIVE WHITENING- stannous fluoride paste, dentifrice

Care One Restore and Defend by

Drug Labeling and Warnings

Care One Restore and Defend by is a Otc medication manufactured, distributed, or labeled by Foodhold U.S.A., Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Stannous Fluoride 0.454% w/w (0.15% fluoride ion)

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

When using this product, if irritation occurs discontinue 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

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

QUESTIONS

Questions or Comments? CALL 1-877-846-9949

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

For product questions or concerns, contact us at 1-877-849-9949

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)

INGREDIENTS AND APPEARANCE

CARE ONE RESTORE AND DEFEND  SENSITIVE WHITENING
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-722
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.454 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-722-19	1 in 1 CARTON	02/11/2019
1		96.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/11/2019

Labeler - Foodhold U.S.A. (809183973)

Registrant - Lornamead (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		078584069	manufacture(41520-722)