MARVELOUS- stannous fluoride paste

Marvelous by

Drug Labeling and Warnings

Marvelous by is a Otc medication manufactured, distributed, or labeled by Batool Pharma International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

Active Ingredients:

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

Purpose

Anticavity, antigingivitis Anti sensitivity toothpaste

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

Warnings

Keep out of reach of children

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

Ask dentist or physician 

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

Directions

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.

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

-ASK A DENTIST

Other information

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:

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):

Email us at batoolpharma@gmail.com

Package Labeling:

INGREDIENTS AND APPEARANCE

MARVELOUS 
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69179-000
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM GLUCONATE (UNII: R6Q3791S76)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC (UNII: J41CSQ7QDS)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STANNOUS CHLORIDE (UNII: 1BQV3749L5)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69179-000-01	1 in 1 CARTON	08/01/2022
1		116 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	08/01/2022

Labeler - Batool Pharma International, Inc. (079242646)