COUNTRY GENT- sodium fluoride powder, dentifrice

Country Gent by

Drug Labeling and Warnings

Country Gent by is a Otc medication manufactured, distributed, or labeled by Heavenly Harvest, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (% by weight)

Sodium Fluoride (0.188%)

Purpose

For Cavity Prevention.

Indication

Aids in prevention of dental decay.

WARNING

KEEP OUT OF REACH OF CHIL-DREN UNDER 6 YRS OF AGE.

If more than used for brushing is swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Calcium Carbonate, Sodium Bicarbonate, Peppermint Oil, Stevia Extract.

Directions For Use

Adults and Children 6 years of age & older: Apply powder to wet toothbrush; completely cover bristles. Brush 30 seconds. Reapply powder as before and brush again. Rinse and expel thoroughly. Brush teeth, after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.  

Children under 6 years of age: Do not use unless directed by a dentist or doctor.

Package/Label Principal Display Panel

Country Gent

toothpaste powder

with fluoride

4 oz. (113 g) Net Wt - over 500 Brushings!

For centuries people used tooth powder as a natural,

safe, effective method for tooth care. Our tooth powder

cleans teeth and promotes healthy

gums by removing plaque.

Gluten Fee, Sulfate Free, Natura

Ingredients Produced by Nature with

Minimal Physical Processing. No

Animal Ingredients or Animal Testing.

Also, try Fluoride Free Products.

Naturally Charming, just as a Country Gent Should Be!

Biodegradable Packaging; MADE IN USA by Heavenly Harvest,

Inc., using ingredients and packaging that are

MADE IN USA

countrygentnatural.com

Questions? Call 229.890.3288

Products safe for customers, employees, & the earth's future.

INGREDIENTS AND APPEARANCE

COUNTRY GENT 
sodium fluoride powder, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66894-0000
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.88 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
PEPPERMINT OIL (UNII: AV092KU4JH)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66894-0000-1	113 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/2012

Labeler - Heavenly Harvest, Inc. (949907877)

Establishment
Name	Address	ID/FEI	Business Operations
Heavenly Harvest, Inc.		949907877	LABEL(66894-0000) , MANUFACTURE(66894-0000) , PACK(66894-0000)