FARMASI WHITENING- sodium fluoride paste, dentifrice 
Farmasi US LLC

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Farmasi Whitening Toothpaste

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:

25g Label25g Tube25g Inner Label

112g Package Labeling:

tubebox

FARMASI WHITENING 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74690-012
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74690-012-011 in 1 BOX04/15/2021
1112 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:74690-012-021 in 1 BOX09/25/2021
225 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02104/15/2021
Labeler - Farmasi US LLC (113303351)

Revised: 11/2023
Document Id: 09734a55-efb4-3b22-e063-6394a90ad2d2
Set id: 25b3608e-abed-41ca-9971-21981b8a4610
Version: 3
Effective Time: 20231105
 
Farmasi US LLC