EQUATE REPAIR AND PROTECT- stannous fluoride paste, dentifrice

Equate Repair and Protect by

Drug Labeling and Warnings

Equate Repair and Protect by is a Otc medication manufactured, distributed, or labeled by Walmart, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Anticavity / Antihypersensitivity

INDICATIONS & USAGE

Aids in the prevention of dental cavities * builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

WARNINGS

When using this product, if irriation 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

adults and children 12 years of age or older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush * brush teeth thoroughly for at least one minute, preferrably after each meal or at least twice a day (morning and evening) or as recommended 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.

OTHER SAFETY INFORMATION

products containing stannous fluoride may produce surface staining of the teeth. Adequade tooth brushing 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 30ºC (86ºF)

INACTIVE INGREDIENT

glycerin, water, hydrated silica, pentasodium triphosphate, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EQUATE REPAIR AND PROTECT 
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79903-082
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g

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

Product Characteristics
Color	white (White to white with slight yellow hue)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79903-082-29	1 in 1 CARTON	09/23/2021
1		96 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 Drug	M021	09/23/2021

Labeler - Walmart (051957769)

Registrant - Lornamead (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	manufacture(79903-082) , pack(79903-082)