SPEARMINT WHITENING WITH HEMP OIL- sodium monofluorophosphate paste, dentifrice
Whole Foods

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.

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Active ingredient Purpose

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion) ...... Anticavity

Use aids in the 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 per day, or as directed by a dentist or doctor. * Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). * Supervise children as necessary until capable of using without supervision. * Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients glycerin, water, calcium carbonate, hydrated silica, xylitol, sodium bicarbonate, carrageenan, cannabis sativa (hemp) seed oil, sodium auroyl sarcosinate, natural flavor, zinc citrate, benzyl alcohol

Tube Artwork Spearmint with Fluoride

Toothpaste

with Hemp Seed Oil

Cavity Fighting & Whitening Net wt 5.5 oz (156g)

SPEARMINT WHITENING WITH HEMP OIL
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42681-0019
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
XYLITOL (UNII: VCQ006KQ1E)
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARRAGEENAN (UNII: 5C69YCD2YJ)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ZINC CITRATE (UNII: K72I3DEX9B)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42681-0019-1	156 g in 1 TUBE; Type 0: Not a Combination Product	04/29/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	04/29/2020

Labeler - Whole Foods (196175616)

Registrant - Lornamead (080046441)

Name	Address	ID/FEI	Business Operations
Establishment
Lornamead		080046418	manufacture(42681-0019)

Revised: 1/2023

Document Id: f2152a95-708e-2f93-e053-2995a90a0349

Set id: a4714db7-abc4-1eff-e053-2995a90a7740

Version: 2

Effective Time: 20230112

Whole Foods