EQUATE BEAUTY ENAMEL PROTECTION GENTLE WHITENING FOR SENSITIVE TEETH- potassium nitrate, sodium fluoride paste

equate beauty Enamel Protection Gentle Whitening For Sensitive Teeth by

Drug Labeling and Warnings

equate beauty Enamel Protection Gentle Whitening For Sensitive Teeth by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc, Lornamead, Lornamead Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.15% w/v fluoride ion

PURPOSE

Purpose

Antihypersensitivity

Anticavity

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.

See your dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

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 toothbrus

• Brush teeth thoroughly for at least one minute, preferably 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 physician.

SPL UNCLASSIFIED SECTION

Other information Store in a cool, dry place · Keep tube capped when not in use.

INACTIVE INGREDIENT

Inactive ingredients water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

SPL UNCLASSIFIED SECTION

Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments please call 1-888-287-1915.

DISTRIBUTED BY:

Walmart Inc.

Bentonville, AR 72716

†Guards your teeth against sensitivity and the effects of acid wear through normal brushing.

PRINCIPAL DISPLAY PANEL

equate

ENAMEL PROTECTION GREEN MINT FLAVOR

GENTLE WHITENING FOR SENSITIVE TEETH

DAILY ANTI-CAVITY TOOTHPASTE WITH FLUORIDE

Helps harden tooth enamel with acid protection formula †

NET WT 4.0 OZ (113g)

INGREDIENTS AND APPEARANCE

EQUATE BEAUTY ENAMEL PROTECTION GENTLE WHITENING FOR SENSITIVE TEETH 
potassium nitrate, sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-861
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-861-89	1 in 1 BOX	11/02/2018
1		113 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	11/02/2018

Labeler - Wal-Mart Stores Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(49035-861)