FDA.reportPublic FDA data

CinnaFresh

Manufacturer
Bob Barker Company Inc. | SKYLARK CMC PVT. LTD.
Effective date
2018-01-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:03:01

Label at a glance#

ProductCinnaFresh Anti-cavity
Active ingredientSodium Fluoride
Label structure7 sections

Dosage and administration

Do not swallow Supervise children as necessary until capable of using without supervision Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). 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 a doctor. Children under 2 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not swallow

  • Supervise children as necessary until capable of using without supervision
  • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
  • 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 a doctor.
  • Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Purified Water, Precipitated Silica, Sodium Lauryl Sulphate, Carboxymethyl Cellulose, Flavor, Polyethylene Glycol 32, Sodium Saccharin, Sodium Benzoate, FD&C Red # 40.

PRINCIPAL DISPLAY PANEL - 24 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CinnaFresh
anticavity gel toothpaste

NET WT. 0.85 OZ
(24 GRAMS)

Principal Display Panel - 24 g Tube Label
Principal Display Panel - 24 g Tube Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53247-103-612020-02-19C16284748780-19d75b9d1-19b3-f424-e053-dadaa90a57ceCinnaFresh Anti-cavity
53247-103-612020-01-31C16284748780-19d75b9d1-19b3-f424-e053-dadaa90a57ceCinnaFresh Anti-cavity

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53247-10353247-103-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium Fluoride8ZYQ1474W7ACTIM
Sorbitol506T60A25RIACT
Water059QF0KO0RIACT
Sodium Lauryl Sulfate368GB5141JIACT
Carboxymethylcellulose05JZI7B19XIACT
Saccharin SodiumSB8ZUX40TYIACT
Sodium BenzoateOJ245FE5EUIACT
FD&C Red No. 40WZB9127XOAIACT

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
59f14bde-462e-4b0d-9e6e-d7427147d0981d197c49-e21f-4107-9a27-02a89b78e9a32018-01-12WarningsExact identifier
spl id: 59f14bde-462e-4b0d-9e6e-d7427147d098
spl set id: 1d197c49-e21f-4107-9a27-02a89b78e9a3

Reported adverse events (FAERS/openFDA)#

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