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 6 years of age: Do not use unless directed by a doctor or dentist.

INACTIVE INGREDIENT

Calcium Carbonate, Water, Sorbitol, PEG-400, Sodium Lauryl Sulfate, Hydrated Silica, Cellulose Gum, Flavor, Hydroxypropyl Guar, , Sodium Sacharine, Methylparaben, Propylparaben

image description

DAWNMIST FLUORIDE TOOTH
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70766-015
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CALCIUM CARBONATE (UNII: H0G9379FGK)
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70766-015-01	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:70766-015-02	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:70766-015-03	144 in 1 BOX	04/29/2024
3		43 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:70766-015-04	144 in 1 BOX	04/29/2024
4		78 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC:70766-015-05	60 in 1 BOX	04/29/2024
5		135 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC:70766-015-06	48 in 1 BOX	04/29/2024
6		181.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	01/04/2024

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

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