70766-016 Dinosuair Anticavity Gel Tooth Paste

70766-016 Dinosuair Anticavity Gel Tooth Paste
SPL v1
SPL
SPL Set ID cccb3122-891b-4168-81ee-d8e97706caee
Route
DENTAL
Published
Effective Date 2024-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.14 g)
Inactive Ingredients
Water Sorbitol Hydrated Silica Sodium Lauryl Sulfate Calcium Carbonate Polyethylene Glycol 400 Saccharin Sodium Sodium Benzoate Xylitol Carboxymethylcellulose Sodium Fd&c Blue No. 1 Fd&c Yellow No. 5 Sodium Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-21

Description

SODIUM FLUORIDE   0.24%(0.14 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>

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

SODIUM FLUORIDE   0.24%(0.14 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>

Uses

Aids in the prevention of dental cavities.

Section 50565-1

Keep out of reach of children.

Section 51945-4

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.

Directions
  • Adults and children 2 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.
  • Do not swallow
  • To minimize swallowing, use a pea sized amount in children under 6 years
  • Supervise children brushing untill good habits are established
  • Children under 2 years of age: Consult a dentist or physician.
Active Ingredients

SODIUM FLUORIDE   0.24%(0.14 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

Sorbitol,, Water, Silica, PEG-400, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Xanthan Gum, Xylitor, Sodium Sacharine, Sodium Benzoate, Sodium Phosphate, CI 42090, CI 19140


Structured Label Content

Uses

Aids in the prevention of dental cavities.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose

Anticavity

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.

Directions
  • Adults and children 2 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.
  • Do not swallow
  • To minimize swallowing, use a pea sized amount in children under 6 years
  • Supervise children brushing untill good habits are established
  • Children under 2 years of age: Consult a dentist or physician.
Active Ingredients (Active ingredients)

SODIUM FLUORIDE   0.24%(0.14 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)

Sorbitol,, Water, Silica, PEG-400, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Xanthan Gum, Xylitor, Sodium Sacharine, Sodium Benzoate, Sodium Phosphate, CI 42090, CI 19140


Advanced Ingredient Data


Raw Label Data

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