FDA.reportPublic FDA data

The Natural Dentist

Manufacturer
Caldwell Health LLC | GORAN PHARMA PRIVATE LIMITED
Effective date
2022-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:42:49

Label at a glance#

ProductThe Natural Dentist Charcoal Whitening Fluoride
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Storage and handling

Other information Store standing up with cap tightly closed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

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

OTC - PURPOSE SECTION

Purpose

Anticavity

INDICATIONS & USAGE SECTION

Use

Aids in the prevention of dental cavities.

WARNINGS SECTION

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if the safety seal is missing or broken.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 2 years of age and olderBrush teeth thoroughly, preferably after each meal or at least twice or as directed by a dentist or physician.
Children 2 to 6 yearsUse only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing).
Children under 2 yearsAsk a dentist or physician.

STORAGE AND HANDLING SECTION

Other information

Store standing up with cap tightly closed.

INACTIVE INGREDIENT SECTION

Inactive ingredients Sorbitol, hydrated silica, glycerin, xylitol, water, charcoal powder, cocamidopropyl betaine, sodium cocoyl glycinate, flavor, cellulose gum, xanthan gum, Citrus grandis (grapefruit) seed extract, Aloe barbadensis leaf juice.

OTC - QUESTIONS SECTION

Questions?

Call 1-888-317-4402, weekdays 9 to 5 ET.

SPL UNCLASSIFIED SECTION

Manufactured for Revive Personal Products Company,

Allendale, NJ 07401

© 2018 Revive Personal Products Company.

Made in USA. Vegan. Not tested on animals.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NO SLS! NEW!

THE NATURAL DENTIST

CHARCOAL WHITENING FLUORIDE TOOTHPASTE

with ACTIVATED CHARCOAL

  • Prevents Cavities
  • Whitens Teeth
  • Strengthens Tooth Enamel
  • Removes Stains
  • Freshens Breath

Safe for Everyday Use

COCOMINT™ FLAVOR

No artificial flavors or colors.

NET WT 5.0 OZ (141 g)

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
34362-0242-22021-12-29C16284748780-1ab0e2407-283c-f274-e053-dbdaa90a6471The Natural Dentist Charcoal Whitening Fluoride Toothpaste
34362-0242-22020-09-27C16284748780-1ab0e2407-283c-f274-e053-dbdaa90a6471The Natural Dentist Charcoal Whitening Fluoride Toothpaste
34362-0242-22020-09-25C16284748780-1ab0e2407-283c-f274-e053-dbdaa90a6471The Natural Dentist Charcoal Whitening Fluoride Toothpaste
34362-0242-22020-07-22C16284748780-1ab0e2407-283c-f274-e053-dbdaa90a6471The Natural Dentist Charcoal Whitening Fluoride Toothpaste

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34362-024234362-0242-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACTIVATED CHARCOAL2P3VWU3H10IACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM COCOYL GLYCINATEXLU9KH03XMIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XANTHAN GUMTTV12P4NEEIACT
XYLITOLVCQ006KQ1EIACT
GRAPEFRUIT SEED OIL598D944HOLIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
77aa9b36-6dc8-4f40-8c59-e686c2dbe6f2812d1e3f-c03a-e4a5-e053-2a91aa0ad5e42023-10-31WarningsExact identifier
spl set id: 812d1e3f-c03a-e4a5-e053-2a91aa0ad5e4

Reported adverse events (FAERS/openFDA)#

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