Rael Himalayan Pink Salt Fresh soothing mint

Manufacturer
Rael, Inc. | Sangleaf Pharm., Co Ltd
Effective date
2019-09-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 00:10:22

Label at a glance#

ProductRael Himalayan Pink Salt Fresh soothing mint
Active ingredientSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE
Label structure8 sections

Indications and uses

Helps protect against cavities

Dosage and administration

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

Label contents#

Full prescribing information#

active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride

Sodium monofluorophosphate

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Helps protect against cavities

Warnings

WARNINGS SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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.

Rael Himalayan Pink Salt Toothpaste (Fresh soothing mint)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rael Himalayan Pink Salt Toothpaste (Fresh soothing mint)Rael Himalayan Pink Salt Toothpaste (Fresh soothing mint)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72863-102-022020-07-22C16284748780-1ab0e2407-31ae-f274-e053-dbdaa90a6471Rael Himalayan Pink Salt Toothpaste (Fresh soothing mint)

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72863-10272863-102-01, 72863-102-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d0012240-3a29-c10b-e053-2995a90a0f2892d8d203-1ff1-067b-e053-2995a90ab1b82021-11-04WarningsExact identifier
spl set id: 92d8d203-1ff1-067b-e053-2995a90ab1b8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.