THE NATURAL DENTIST PEPPERMINT TWIST- fluoride paste, dentifrice
Caldwell Health LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

THE NATURAL DENTIST
ALL IN ONE
ANTICAVITY TOOTHPASTE

NO SLS!

NO SODIUM LAURYL SULFATE.

NO ARTIFICIAL FLAVORS OR COLORS.

with Purified Aloe Vera

Prevents Cavities
Whitens Teeth
Strengthens Tooth Enamel
Fights Tartar
Freshens Breath

Peppermint Twist

NET WT. 5.0 OZ (141g)

Our promise:

The Natural Dentist products are scientifically formulated using carefully sourced botanical, herbal and mineral ingredients. We will not use synthetic flavors, colors, or preservatives. Nor will we use alcohol or sodium lauryl sulfate (SLS). Synthetic ingredients are used in certain of our products when no satisfactory substitute can be found in nature that meets our formulation or therapeutic goals.

Active ingredient

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

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

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.

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.

Other information

Store standing up with cap tightly closed.

Inactive ingredients

Vegetable glycerin, hydrated silica, sorbitol, water, xylitol, Aloe barbadensis leaf juice, cocamidopropyl betaine, sodium cocoylglycinate, cellulose gum, titanium dioxide, Echinacea angustifolia extract, natural flavors, Hydrastis canadensis (goldenseal) extract, Calendufa officinalis extract, xanthan gum, citric acid, zinc citrate, Citrus grandis (grapefruit) seed extract.

Questions?

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

Manufactured for Revive Personal Products Company,

Madison, NJ 07940

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THE NATURAL DENTIST PEPPERMINT TWIST
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:34362-0234
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2430 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
GOLDENSEAL (UNII: ZW3Z11D0JV)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ZINC CITRATE (UNII: K72I3DEX9B)
CITRUS MAXIMA SEED (UNII: 083X55C543)

Product Characteristics
Color	white (Off White)	Score
Shape		Size
Flavor	PEPPERMINT (Peppermint Twist)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:34362-0234-2	1 in 1 BOX	04/11/2018	05/14/2018
1		142 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	04/11/2018	05/14/2018

Labeler - Caldwell Health LLC (828558713)

Name	Address	ID/FEI	Business Operations
Establishment
Lornamead Inc.		126440440	manufacture(34362-0234)

Name	Address	ID/FEI	Business Operations
Establishment
GORAN PHARMA PRIVATE LIMITED		862174088	manufacture(34362-0234)

Revised: 4/2018

Document Id: 37cb79d9-e899-4207-a9a3-2853264b7900

Set id: 3d5d9c92-4602-4029-869d-67f3ff5215c4

Version: 10

Effective Time: 20180418

Caldwell Health LLC