MedPath

Signature Care Sensitive

5820289, 5820040 Signature Care Maximum Strength Sensitive

Approved
Approval ID

83225fe5-0490-eb4b-e053-2a91aa0a6879

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Safeway

DUNS: 009137209

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Potassium nitrate, Sodium fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21130-351
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Potassium nitrate, Sodium fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (14)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM TRIPOLYPHOSPHATEInactive
Code: 5HK03SA80J
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SODIUM METHYL COCOYL TAURATEInactive
Code: JVL98CG53G
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.15 g in 100 g
Code: 8ZYQ1474W7
Classification: ACTIM
POTASSIUM NITRATEActive
Quantity: 5 g in 100 g
Code: RU45X2JN0Z
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/2/2019

5820289 2821289R4Signature Care™

MAXIMUM STRENGTH

SENSITIVETOOTHPASTE WITH FLUORIDE

FOR SENSITIVE TEETH & CAVITY PROTECTION

RELIEVES PAINFUL SENSITIVITY

Extra Whitening

NET WT 4 OZ (113 g)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/2/2019

Uses

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 3/2/2019

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

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/2/2019

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/2/2019

Purpose

Antihypersensitivity

Anticavity

WARNINGS SECTION

LOINC: 34071-1Updated: 3/2/2019

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 SECTION

LOINC: 34068-7Updated: 3/2/2019

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 SECTION

LOINC: 44425-7Updated: 3/2/2019

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/2/2019

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

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Signature Care Sensitive - FDA Drug Approval Details