MedPath

Kroger Enamel Protection Sensitive

5820255 Kroger Enamel Protection Sensitive Gentle Whitening

Approved
Approval ID

82b9a954-2a53-ac56-e053-2991aa0abd0e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Kroger Company

DUNS: 006999528

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 Code30142-362
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 (12)

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

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/25/2019

Kroger® Enamel Protection

GENTLE WHITENING FOR SENSITIVE TEETH

  • Daily Anti-cavity Toothpaste with Flouride
  • Helps Harden Tooth Enamel with Acid Protection Formula

Mint Breeze

NET WT 4 OZ (113 g)

Kroger EnamelProt 2821255R1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/25/2019

Uses

  • aids in the prevention of dental cavities
  • aids in reducing sensitivity

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 2/25/2019

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

QUALITY GUARANTEE

800-632-6900 • www.kroger.com

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/25/2019

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.15% w/v fluoride ion

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/25/2019

Purpose

Antihypersensitivity

Anticavity

WARNINGS SECTION

LOINC: 34071-1Updated: 1/30/2019

Warnings

If pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

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.

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: 2/25/2019

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) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth *Children under 12 years of age: consult a dentist or a doctor

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/5/2019

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 2/25/2019

Store in a cool dry place

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Kroger Enamel Protection Sensitive - FDA Drug Approval Details