Label: COUNTRY GENT- sodium fluoride powder, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 66894-0000-1 - Packager: Heavenly Harvest, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated February 14, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (% by weight)
- Purpose
- Indication
- WARNING
- KEEP OUT OF REACH OF CHIL-DREN UNDER 6 YRS OF AGE.
- Inactive Ingredients
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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.
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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.
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INGREDIENTS AND APPEARANCE
COUNTRY GENT
sodium fluoride powder, dentifriceProduct 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)