COUNTRY GENT- sodium fluoride powder, dentifrice 
Heavenly Harvest, Inc.

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.

----------

Drug Facts

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 label

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.

COUNTRY GENT 
sodium fluoride powder, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66894-0000
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.88 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66894-0000-1113 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/2012
Labeler - Heavenly Harvest, Inc. (949907877)
Establishment
NameAddressID/FEIBusiness Operations
Heavenly Harvest, Inc.949907877LABEL(66894-0000) , MANUFACTURE(66894-0000) , PACK(66894-0000)

Revised: 2/2012
Document Id: b0a72b13-14a5-4086-a05c-6c9a515374ce
Set id: b0a72b13-14a5-4086-a05c-6c9a515374ce
Version: 1
Effective Time: 20120214
 
Heavenly Harvest, Inc.