FDA.reportPublic FDA data

Marvelous

Manufacturer
Batool Pharma International, Inc.
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:21:06

Label at a glance#

ProductMarvelous
Active ingredientSTANNOUS FLUORIDE
Label structure8 sections

Indications and uses

Aid in the preventing of dental cavities  Helps prevent gingivitis Helps interfere toothpaste with harmful effects of plaque bacterias associated with gingivitis  Helps control plaque bacteria that contribute to the development of gingivitis

Dosage and administration

Adult and children 12 yrs. of age and older, brush teeth thoroughly, preferably after each meal or at least twice a day, or directed by a dentist or physician. -ASK A DENTIST Do not swallow  Children under 12 yrs. of age 

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Stannous Fluoride 0.454 % (0.14% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity, antigingivitis Anti sensitivity toothpaste

Uses:

INDICATIONS & USAGE SECTION

Aid in the preventing of dental cavities 

  • Helps prevent gingivitis
  • Helps interfere toothpaste with harmful effects of plaque bacterias associated with gingivitis 
  • Helps control plaque bacteria that contribute to the development of gingivitis

Warnings

WARNINGS SECTION

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

under 12 yrs. Of age. If swallowed, get medical help or contact a poison control center right away. 

Ask dentist or physician 

OTC - ASK DOCTOR SECTION

before use, if you have allergy or have allergic reaction to medications or ingredients in this product.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children 12 yrs. of age and older, brush teeth thoroughly, preferably after each meal or at least twice a day, or directed by a dentist or physician.

-ASK A DENTIST

  • Do not swallow 
  • Children under 12 yrs. of age 

Other information

SPL UNCLASSIFIED SECTION

Products containing stannous fluoride may produce surface staining of the teeth

  • adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
  • This toothpaste is specially formulated to help prevent staining

Other ingredients:

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Carrageenan, Sodium Gluconate, Xanthan Gum, Zinc, Citrate, Stannous Chloride, Sodium Saccharin, Sodium Hydroxide, Sucralose, Titanium Dioxide, Tea Tree Oil (Melaleuca Alternafolia: Antibacterial, Anti Vital, Anti Fungus, Antiseptic)

Question(s):

OTC - QUESTIONS SECTION

Email us at batoolpharma@gmail.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69179-00069179-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINCJ41CSQ7QDSIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
STANNOUS CHLORIDE1BQV3749L5IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM HYDROXIDE55X04QC32IIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TEA TREE OILVIF565UC2GIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARRAGEENAN5C69YCD2YJIACT
SODIUM GLUCONATER6Q3791S76IACT
XANTHAN GUMTTV12P4NEEIACT
STANNOUS FLUORIDE3FTR44B32QACTIM

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
2a7cc59d-5175-0e47-e063-6394a90aa04b02a3d1a8-1c0b-4cd6-9ba9-64a9233f0faf2024-12-30WarningsExact identifier
spl set id: 02a3d1a8-1c0b-4cd6-9ba9-64a9233f0faf

Reported adverse events (FAERS/openFDA)#

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