THE NATURAL DENTIST PEPPERMINT TWIST- 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 Consumer Health LLC, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Uses

aids in the prevention of dental cavities

WARNINGS

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.

DOSAGE & ADMINISTRATION

Children 2 to 6 years of age: 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

Hydrated Silica, Glycerin, Sorbitol, Water, Xylitol, Cocamidopropyl Betaine, Sodium Cocoyl Glycinate, Aloe barbadensis Leaf Juice, Cellulose Gum, Citrus grandis (Grapefruit) Seed Extract, Titanium Dioxide, Xanthan Gum, Flavor.

PRINCIPAL DISPLAY PANEL

mm1.jpg

INGREDIENTS AND APPEARANCE

THE NATURAL DENTIST  PEPPERMINT TWIST
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34362-0270
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Product Characteristics
Color	white (Off White)	Score
Shape		Size
Flavor	MINT (Cinnimon Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34362-0270-1	142 g in 1 TUBE

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

Labeler - Caldwell Consumer Health LLC (828558713)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		126440440	manufacture(34362-0270) , pack(34362-0270)