HIMALAYAN PINK SALT FRESH SOOTHING MINT- sodium fluoride, sodium monofluorophosphate paste, dentifrice

Himalayan Pink Salt Fresh Soothing Mint by

Drug Labeling and Warnings

Himalayan Pink Salt Fresh Soothing Mint by is a Otc medication manufactured, distributed, or labeled by Rael, Inc., Sangleaf Pharm., Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

active ingredient

Sodium Fluoride

Sodium monofluorophosphate

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

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

Purpose

Anticavity

Uses

Helps protect against cavities

Warnings

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

Directions

Adults and children 6 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 physician.

Children 2 to 6 years

Use only a pea sized amount and supervise child’s brushing and rinsing (to minimize swallowing).

Children under 2 years

Ask a dentist or physician

Inactive Ingredients

Silicon dioxide, Sodium pyrophosphate, Glycerin, Sorbitol solution, Xanthan gum, Cellulose gum, Sodium lauryl sulfate, Sodium saccharin, Ferric oxide, Sodium chloride, Bamboo salt, Himalayan pink salt, Rosemary extract, Scutellaria baicalensis root extract, Chamomile extract, Xylitol, Calendula extract, L-Menthol, Mint flavor, purified water.

Himalayan Pink Salt Toothpaste (Fresh Soothing Mint)

INGREDIENTS AND APPEARANCE

HIMALAYAN PINK SALT FRESH SOOTHING MINT 
sodium fluoride, sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72863-100
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.768 g  in 120 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.036 g  in 120 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)	0.6 g  in 120 g

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72863-100-02	1 in 1 CARTON	02/27/2019
1	NDC: 72863-100-01	120 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 final	part355	02/27/2019

Labeler - Rael, Inc. (087378348)

Registrant - Rael, Inc. (087378348)

Establishment
Name	Address	ID/FEI	Business Operations
Sangleaf Pharm., Co Ltd		689847343	manufacture(72863-100)