THE NATURAL DENTIST GROOVY GRAPE- 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, GORAN PHARMA PRIVATE LIMITED. 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 teeth thoroughly preferably after each meal or at least twice a day, or as directed by a dentist or physician.
• Children 2 to 6 years: Use only a pea sized amount and supervise children's brushing and rinsing (to minimize swallowing.)
• Children under 2 years: Ask a dentist or physician.

STORAGE AND HANDLING

Other information

Store tube standing up with cap tightly closed.

INACTIVE INGREDIENT

Inactive ingredients Glycerin, water, sorbitol, hydrated silica, xylitol, Aloe barbadensis leaf juice, cocamidopropyl betaine, sodium cocoyl glycinate, cellulose gum, flavor, xanthan gum, Citrus grandis (grapefruit) seed extract, mica, Stevia rebaudiana extract, titanium dioxide,

QUESTIONS

Questions?

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

SPL UNCLASSIFIED SECTION

Manufactured for Revive Personal Care Products Company Madison, NJ 07940

©2018 Revive Personal Products Company. Made in the USA. Vegan. Not tested on animals.

PRINCIPAL DISPLAY PANEL

THE NATURAL DENTIST®

CAVITY ZAPPER®

ANTICAVITY GEL TOOTHPASTE FOR KIDS

• Helps Prevent Cavities
• Strengthens Tooth Enamel
• Cleans Away Plaque & Stains

NOT YUCKY GRAPE

No Sodium Lauryl Sulfate

No artificial flavors or colors.

NET WT 5.0 OZ (141 g)

INGREDIENTS AND APPEARANCE

THE NATURAL DENTIST  GROOVY GRAPE
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34362-0233
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XANTHAN GUM (UNII: TTV12P4NEE)
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
MICA (UNII: V8A1AW0880)
SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)

Product Characteristics
Color	pink (Faint Pink to clear)	Score
Shape		Size
Flavor	GRAPE (Grape)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34362-0233-1	142 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2011	05/23/2013
2	NDC: 34362-0233-2	141 g in 1 TUBE; Type 0: Not a Combination Product	05/23/2013

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 (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		078584069	manufacture(34362-0233)