DAWNMIST GEL FLUORIDE TOOTH- sodium fluoride paste, dentifrice

DawnMist Gel Fluoride Tooth by

Drug Labeling and Warnings

DawnMist Gel Fluoride Tooth 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   0.22%(0.10 w/v Fluoride ion)

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Purpose

Anticavity

Uses

Aids in the prevention of dental cavities.

Warnings

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

Keep out of reach of children.

Directions

• Do not swallow, supervise children as necessary until capable of using without supervision. Instruct children under 12 years of age in good brushing and rinsing habits (to minimizing swallowing). 
• Adults and children 6 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a doctor.
• Children under 2 years of age: consult a doctor or dentist.

INACTIVE INGREDIENT

Sorbitol, Hydrated Silica, Glycerin, Water, PEG-400, Sodium Lauryl Sulfate, Cellulose Gum, Xanthan gum, flavor, Sodium Benzoate, Sodium sacharine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAWNMIST GEL FLUORIDE TOOTH 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70766-014
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70766-014-01	5 in 1 CARTON	04/29/2024
1		144 in 1 BOX
1		17 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70766-014-02	5 in 1 CARTON	04/29/2024
2		144 in 1 BOX
2		24 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 70766-014-03	144 in 1 BOX	04/29/2024
3		43 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 70766-014-04	144 in 1 BOX	04/29/2024
4		78 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	01/04/2024

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(70766-014)