BEYOND ACTIVATED COCONUT CHARCOAL AND SEA SALT- sodium fluoride paste, dentifrice

Beyond Activated Coconut Charcoal and Sea Salt by

Drug Labeling and Warnings

Beyond Activated Coconut Charcoal and Sea Salt by is a Otc medication manufactured, distributed, or labeled by Beyond International Inc. 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

Uses

• Aids in prevention of dental cavities.

WARNINGS

Warnings

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age.

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

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 doctor.
• instruct children under 6 years of age in good brushing or rinsing habits (to minimize swallowing)
• supervise children as necessary until good habits are established
• children under 2 years: ask a dentist or doctor
  

INACTIVE INGREDIENT

Inactive ingredients Sorbitol, Silica, Water (Aqua), Propylene Glycol, Activated Charcoal, PEG-1450, Sodium Lauryl Sulfate, PEG-400, Cellulose Gum, Sodium Hydroxide, Hydroxyethylellulose, Sea Salt, Sodium Saccharin, Sodium Benzoate, Disodium EDTA, Calcium Peroxide, Polyvinyl Alcohol, Ethylcellulose, Glycerin, Grape (Vitis Vinifera) Seed Oil, Eugenol, Flavor, Titanium Dioxide

QUESTIONS

Questions or comments? 866-695-6452

SPL UNCLASSIFIED SECTION

Manufactured by:

BEYOND® INTERNATIONAL INC.

711 Julie Rivers Dr.

Sugar Land, TX 77478 USA

©2020 BEYOND® INTERNATIONAL INC.

www.beyonddent.com

PRINCIPAL DISPLAY PANEL

Vegan

beyond®

Activated Coconut CHARCOAL & SEA SALT

FLUORIDE ANTICAVITY TOOTHPASTE

• Deeply Whitens
• Fights Cavities
• Reduces Plaque
• Soothes Gums

NET WT. 4.6 OZ (130g)

INGREDIENTS AND APPEARANCE

BEYOND ACTIVATED COCONUT CHARCOAL AND SEA SALT 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42199-008
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
GRAPE SEED OIL (UNII: 930MLC8XGG)
EUGENOL (UNII: 3T8H1794QW)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SEA SALT (UNII: 87GE52P74G)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42199-008-04	1 in 1 CARTON	11/10/2021	11/15/2026
1		130 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	11/10/2021	11/15/2026

Labeler - Beyond International Inc (080721790)

Establishment
Name	Address	ID/FEI	Business Operations
Beyond International Inc		080721790	manufacture(42199-008)