365 Everyday Value Cavity Fighting And Whitening (Sodium Monoflourophosphate) Paste, Dentifrice [Whole Foods Market, Inc.] -

365 EVERYDAY VALUE CAVITY FIGHTING AND WHITENING (SODIUM MONOFLOUROPHOSPHATE) PASTE, DENTIFRICE [WHOLE FOODS MARKET, INC.]
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NDC	42681-5002-9
Set ID	83704717-19bc-2634-e053-2991aa0a2979
Category	HUMAN OTC DRUG LABEL
Packager	Whole Foods Market, Inc.
Generic Name
Product Class
Product Number
Application Number	PART355

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredient

Sodium monofluorophosphate 0.76%
PURPOSE

Purpose

Anticavity
INDICATIONS & USAGE

Uses aids in the prevention of dental caviites
WARNINGS

Warnings

Keep out of reach of children under 6 years of age. 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 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice per day, or as directed by a dentist or doctor.
- Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
- Supervise children as necessary until capable of using without supervision.
- children under 2 years of age: consult a dentist or doctor.
INACTIVE INGREDIENT

Inactive ingredients glycerin, water, calcium carbonate, hydrated silica, xylitol, sodium bicarbonate, carrageenan, sodium lauroyl sarcosinate, natural flavor, zinc citrate, benzyl alcohol
STORAGE AND HANDLING

Other information

Store in a cool dry place. Tamper evident, use only if box seal is intact. Keep tube capped when not in use.
QUESTIONS
Questions or comments?
- customer.questions@wholefoods.com
- 1 (844) 936-8255
SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

WHOLE FOODS MARKET

AUSTIN, TX 78703

www.wholefoodsmarket.com

MADE IN USA FROM DOMESTIC AND IMPORTED INGREDIENTS
PRINCIPAL DISPLAY PANEL

365 EVERYDAY VALUE

PEPPERMINT

FLUORIDE TOOTHPASTE

CAVITY FIGHTING & WHITENING

Helps fight tartar

Made with Xylitol

Made without Dyes

Made without Sodium Lauryl Sulfate or Laureth Sulfate

NET WT 5.5 OZ (156g)

INGREDIENTS AND APPEARANCE

365 EVERYDAY VALUE CAVITY FIGHTING AND WHITENING
sodium monoflourophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42681-5002
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCERIN (UNII: PDC6A3C0OX)
CALCIUM CARBONATE (UNII: H0G9379FGK)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
CARRAGEENAN (UNII: 5C69YCD2YJ)
ZINC CITRATE (UNII: K72I3DEX9B)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42681-5002-9	1 in 1 CARTON	03/06/2019
1		156 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 final	part355	03/06/2019

Labeler - Whole Foods Market, Inc. (196175616)

Registrant - Lornamead Inc. (080046418)

Name	Address	ID/FEI	Business Operations
Establishment
Lornamead Inc.		080046418	manufacture(42681-5002)

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Medic

365 EVERYDAY VALUE CAVITY FIGHTING AND WHITENING (SODIUM MONOFLOUROPHOSPHATE) PASTE, DENTIFRICE [WHOLE FOODS MARKET, INC.]

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