ORAL FUSION ANTICAVITY- sodium fluoride paste, dentifrice 
Yangzhou SION Commodity Co.,Ltd

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70766-010

Active ingredients

Sodium Fluoride 0.243%

Purpose

anticavity

Uses

Help protect against cavities

Warnings

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center immediately.

Keep out of reach of children.

Directions

Adult and children 2 years of age and older:


Under 2 years:

INACTIVE INGREDIENT

Sorbitol, Water, Hydrated Silica, Disodium pyrophosphate, Flavor, Sodium Hydroxide, Xanthan Gum, Cellulose Gum, Hydroxypropyl Guar, Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Saccharin, Water, Sodium Lauryl Sulfate, CI 778891

image description

ORAL FUSION ANTICAVITY 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70766-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.11 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITOL (UNII: 506T60A25R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70766-010-0112 in 1 PACKAGE04/28/2022
124 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70766-010-0248 in 1 CARTON04/28/2022
224 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02104/28/2022
Labeler - Yangzhou SION Commodity Co.,Ltd (546806042)
Registrant - Yangzhou SION Commodity Co.,Ltd (546806042)
Establishment
NameAddressID/FEIBusiness Operations
Yangzhou SION Commodity Co.,Ltd546806042manufacture(70766-010)

Revised: 12/2023
Document Id: 0bf9163b-29af-ac40-e063-6394a90a1649
Set id: ddbbadff-9eb7-4a28-e053-2a95a90a168f
Version: 2
Effective Time: 20231208
 
Yangzhou SION Commodity Co.,Ltd