Charcoal and Sea Salt Toothpaste

Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Uses

Aids in prevention of dental cavities.

Warnings

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.

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 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 or comments? 866-695-6452

Manufactured by:

BEYOND® INTERNATIONAL INC.

711 Julie Rivers Dr.

Sugar Land, TX 77478 USA

www.beyonddent.com

Vegan

beyond®

Activated Coconut CHARCOAL & SEA SALT

FLUORIDE ANTICAVITY TOOTHPASTE

Deeply Whitens
Fights Cavities
Reduces Plaque
Soothes Gums

NET WT. 4.6 OZ (130g)

Charcoal Sea Salt TP-FDA

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	11/10/2021	11/15/2026

Labeler - Beyond International Inc (080721790)

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