70766-015 dawnmist

70766-015 dawnmist
SPL v1
SPL
SPL Set ID 6c72752d-eafa-4418-9d0e-aa41a6ba0bde
Route
dental
Published
Effective Date 2024-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.1 g)
Inactive Ingredients
water sorbitol hydrated silica sodium lauryl sulfate methylparaben propylparaben calcium carbonate hydroxypropyl guar (2500-4500 mpa.s at 1%) saccharin sodium

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-01-04

Purpose

Anticavity

Description

SODIUM FLUORIDE   0.22%(0.10 w/v Fluoride ion) <text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)</paragraph> <paragraph/> </text></text></text></text></text>


Medication Information

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.

Uses

Aids in the prevention of dental cavities.

Purpose

Anticavity

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.
Description

SODIUM FLUORIDE   0.22%(0.10 w/v Fluoride ion) <text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)</paragraph> <paragraph/> </text></text></text></text></text>

Section 50565-1

Keep out of reach of children.

Section 51945-4

Active Ingredients

SODIUM FLUORIDE   0.22%(0.10 w/v Fluoride ion)

<text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/>&lt;text xmlns="urn:hl7-org:v3"> &lt;paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)&lt;/paragraph> &lt;paragraph/>&amp;lt;text xmlns="urn:hl7-org:v3"> &amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;lt;/paragraph> &amp;lt;paragraph/>&amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;amp;lt;/paragraph> &amp;amp;lt;paragraph/>&amp;amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;amp;amp;lt;/paragraph> &amp;amp;amp;lt;paragraph/> &amp;amp;amp;lt;/text>&amp;amp;lt;/text>&amp;lt;/text>&lt;/text></text>

Inactive Ingredient

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


Structured Label Content

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.

Uses

Aids in the prevention of dental cavities.

Purpose

Anticavity

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.
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Active Ingredients (Active ingredients)

SODIUM FLUORIDE   0.22%(0.10 w/v Fluoride ion)

<text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/>&lt;text xmlns="urn:hl7-org:v3"> &lt;paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)&lt;/paragraph> &lt;paragraph/>&amp;lt;text xmlns="urn:hl7-org:v3"> &amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;lt;/paragraph> &amp;lt;paragraph/>&amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;amp;lt;/paragraph> &amp;amp;lt;paragraph/>&amp;amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;amp;amp;lt;/paragraph> &amp;amp;amp;lt;paragraph/> &amp;amp;amp;lt;/text>&amp;amp;lt;/text>&amp;lt;/text>&lt;/text></text>

Inactive Ingredient (INACTIVE INGREDIENT)

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


Advanced Ingredient Data


Raw Label Data

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