THE NATURAL DENTIST ORANGE ZEST- fluoride paste, dentifrice
Caldwell Consumer 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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The Natural Dentist Healthy Teeth & Gums

Active ingredient

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

Uses

aids in the prevention of dental cavities

Stop use and ask a dentist if the sensitivity persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Do not use if safety seal is broken.

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.

Directions

Adults and children 2 years and older: Brush teeth thoroughly after meals, at least twice a day or as directed by a dentist. Do not swallow.

Children under 2 years of age: Consult a dentist or physician.

Children under 6: Use a pea sized amount and supervise until good brushing habits are established. Children under 2 years of age: ask a dentist.

Other Information

Store tube standing up with cap tightly closed.

Inactive ingredients

Glycerin, Silica, Water, Sorbitol, Xylitol, Cocamidopropyl Betaine, Aloe barbadensis Leaf Juice, Cellulose Gum, Titanium Dioxide, Echinacea angustifolia Extract, Natural Flavors, Hydrastis canadensis (Goldenseal) Extract, Calendula officinalis Extract, Xanthan Gum, Citric Acid, Citrus grandis (Grapefruit) Seed Extract.

mm1.jpg

Tube Label

THE NATURAL DENTIST ORANGE ZEST
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:34362-0235
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.243 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
GOLDENSEAL (UNII: ZW3Z11D0JV)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Product Characteristics
Color	white (White to Off White)	Score
Shape		Size
Flavor	ORANGE (Orange Zest)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:34362-0235-1	142 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2011	01/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/01/2011	01/01/2014

Labeler - Caldwell Consumer Health LLC (828558713)

Registrant - Lornamead (126440440)

Name	Address	ID/FEI	Business Operations
Establishment
Lornamead		078584069	manufacture(34362-0235)

Revised: 2/2019

Document Id: 81ca08f7-e309-7621-e053-2a91aa0a66ce

Set id: 0f136719-2a49-4b5e-aae6-2551cb797b0c

Version: 2

Effective Time: 20190213

Caldwell Consumer Health LLC