THE NATURAL DENTIST GROOVY GRAPE- 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 Cavity Zapper Toothpaste, Grape

Drug Facts

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 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.

Other information

Store tube standing up with cap tightly closed.

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?

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

Manufactured for Revive Personal Care Products Company Allendale, NJ 07401

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)

image description

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

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)
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/01/2011

Labeler - Caldwell Consumer Health LLC (828558713)

Registrant - GORAN PHARMA PRIVATE LIMITED (862174088)

Name	Address	ID/FEI	Business Operations
Establishment
GORAN PHARMA PRIVATE LIMITED		862174088	manufacture(34362-0233)

Revised: 12/2021

Document Id: 6921ae6b-1f4d-4cc6-8e06-e618fc6fbbde

Set id: 087abbed-1f58-4b45-a76b-a950fa81c18c

Version: 3

Effective Time: 20211229

Caldwell Consumer Health LLC