ORAL FUSION ANTICAVITY- sodium fluoride paste, dentifrice

Oral Fusion Anticavity by

Drug Labeling and Warnings

Oral Fusion Anticavity by is a Otc medication manufactured, distributed, or labeled by Yangzhou SION Commodity Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• Brush teeth thoroughly after meal or at least twice a day, or use as directed by a dentist.

• Do not swallow
• To minimizing swallowing, use only a pea sized amount in children under 6
• and supervise children's brushing and rinsing to minimize swallowing.

Under 2 years:

• Ask a dentist

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORAL FUSION ANTICAVITY 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70766-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.11 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70766-010-01	12 in 1 PACKAGE	04/28/2022
1		24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70766-010-02	48 in 1 CARTON	04/28/2022
2		24 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	04/28/2022

Labeler - Yangzhou SION Commodity Co.,Ltd (546806042)

Registrant - Yangzhou SION Commodity Co.,Ltd (546806042)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou SION Commodity Co.,Ltd		546806042	manufacture(70766-010)