SIGNATURE CARE SENSITIVE MAXIMUM STRENGTH- potassium nitrate, sodium fluoride paste, dentifrice

Signature Care Sensitive by

Drug Labeling and Warnings

Signature Care Sensitive by is a Otc medication manufactured, distributed, or labeled by Safeway, Lornamead Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.24% (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 toothbrush.

• Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
• Children under 12 years of age: consult a dentist or physician.

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929 www.betterlivingbrandsLLC.com

PRINCIPAL DISPLAY PANEL

Signature Care™

MAXIMUM STRENGTH

SENSITIVE TOOTHPASTE WITH FLUORIDE

FOR SENSITIVE TEETH & CAVITY PROTECTION

RELIEVES PAINFUL SENSITIVITY

Extra Whitening

NET WT 4 OZ (113 g)

INGREDIENTS AND APPEARANCE

SIGNATURE CARE SENSITIVE   MAXIMUM STRENGTH
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-351
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-351-19	1 in 1 CARTON	03/02/2019
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	03/02/2019

Labeler - Safeway (009137209)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(21130-351)