FARMASI WHITENING- sodium fluoride paste, dentifrice

Farmasi Whitening by

Drug Labeling and Warnings

Farmasi Whitening by is a Otc medication manufactured, distributed, or labeled by Farmasi US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS

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

PURPOSE

Anticavity

USES

Helps proctect teeth and prevents cavities. Whitens teeth by removing surface stains.

WARNINGS

Keep out of reach of children

under 6 years of age. If more than used for brushing in accidentally swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Adults and children 6 years of age and older: brush teeth thoroughly after meals of at least twice a day, or as directed by a dentist or physician.

INACTIVE INGREDIENTS

Calcium Carbonate, Sorbitol, Water/Aqua, Hydrated Silica, Lauryl Glucoside, Xanthan Gum, Flavour/Aroma, Titanium Dioxide, Sodium Benzoate, Sodium Saccharin, Tea Tree Oil/Melaleuca Alternifolia Leaf Oil, Panax Ginseng Root Extract, Aloe Juice/Aloe Barbadensis Leaf Juice, Salvadora Persica Bark/Root Extract.

Questions or Comments?

info@farmasius.com Monday - Friday (9 a.m - 6 p.m.EST) 1 786 238 7338

25g Package Labeling:

112g Package Labeling:

INGREDIENTS AND APPEARANCE

FARMASI WHITENING 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74690-012
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TEA TREE OIL (UNII: VIF565UC2G)
ASIAN GINSENG (UNII: CUQ3A77YXI)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SALVADORA PERSICA ROOT (UNII: 526M7ZU616)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74690-012-01	1 in 1 BOX	04/15/2021
1		112 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 74690-012-02	1 in 1 BOX	09/25/2021
2		25 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 Drug	M021	04/15/2021

Labeler - Farmasi US LLC (113303351)