THE NATURAL DENTIST WHITENING FLUORIDE- sodium fluoride paste, dentifrice

The Natural Dentist by

Drug Labeling and Warnings

The Natural Dentist by is a Otc medication manufactured, distributed, or labeled by Caldwell Health LLC, Lornamead Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

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

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Use

Aids in the prevention of dental cavities.

WARNINGS

Warnings

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. Do not use if the safety seal is missing or broken.

DOSAGE & ADMINISTRATION

Directions

• Adults and children 2 years of age and older: Brush teeh thoroughly, preferably after each meal or at least twice or as directed by a dentist or physician.
• Children 2 to 6 years: Use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing).
• Children under 2 years: Ask a dentist or physician.

STORAGE AND HANDLING

Other information

Store standing up with cap tightly closed.

INACTIVE INGREDIENT

Inactive ingredients Hydrated silica, glycerin, sorbitol, water, xylitol, cocamidopropyl betaine, sodium cocoylglycinate, Aloe barbadensis leaf juice, cellulose gum, Citrus grandis (grapefruit) seed extract, titanium dioxide, xanthan gum flavor (contains Cinnamomum cassia leaf oil).

QUESTIONS

Questions?

Call 1-888-317-4402, weekdays 9 to 5 ET.

SPL UNCLASSIFIED SECTION

Manufactured for Revive Personal Products Company,

Madison, NJ 07940

© 2018 Revive Personal Products Company.

Made in USA. Vegan. Not tested on animals.

PRINCIPAL DISPLAY PANEL

NO SLS!

THE NATURAL DENTIST

WHITENING FLUORIDE TOOTHPASTE

• Whitens without peroxide
• Prevents Cavities
• Strengthens Teeth
• Freshens Breath

PEPPERMINT TWIST

No artificial flavors or colors.

NET WT 5.0 OZ (141 g)

INGREDIENTS AND APPEARANCE

THE NATURAL DENTIST  WHITENING FLUORIDE
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34362-0240
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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CINNAMON OIL (UNII: E5GY4I6YCZ)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34362-0240-2	1 in 1 BOX	12/01/2018
1		141 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 final	part355	12/01/2018

Labeler - Caldwell Health LLC (828558713)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(34362-0240)