Kroger Enamel Protection Sensitive Gentle Whitening (Potassium Nitrate, Sodium Fluoride) Paste, Dentifrice [Kroger Company] -

KROGER ENAMEL PROTECTION SENSITIVE GENTLE WHITENING (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [KROGER COMPANY]
PDF | XML

NDC	30142-362-99
Set ID	82b9a954-2a53-ac56-e053-2991aa0abd0e
Category	HUMAN OTC DRUG LABEL
Packager	Kroger Company
Generic Name
Product Class
Product Number
Application Number	PART356

View All Sections

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.15% w/v fluoride ion
PURPOSE

Purpose

Antihypersensitivity

Anticavity
INDICATIONS & USAGE
Uses
- aids in the prevention of dental cavities
- aids in reducing sensitivity
WARNINGS

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
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

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

Store in a cool dry place
SPL UNCLASSIFIED SECTION

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

QUALITY GUARANTEE

800-632-6900 • www.kroger.com
PRINCIPAL DISPLAY PANEL
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)

INGREDIENTS AND APPEARANCE

KROGER ENAMEL PROTECTION SENSITIVE GENTLE WHITENING
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-362
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:30142-362-99	1 in 1 CARTON	02/25/2019
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/25/2019

Labeler - Kroger Company (006999528)

Registrant - Lornamead Inc. (080046418)

Name	Address	ID/FEI	Business Operations
Establishment
Lornamead Inc.		080046418	manufacture(30142-362)

View All Sections

Medic

KROGER ENAMEL PROTECTION SENSITIVE GENTLE WHITENING (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [KROGER COMPANY]

Related Drugs