85162-003

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (0.1 g)

Inactive Ingredients

water sorbitol hydrated silica sodium lauryl sulfate xanthan gum trisodium phosphide sodium benzoate xylitol fd&c blue no. 1 saccharin sodium

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2025-01-16

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.

Do not use if the inner foil is torn, cut, or missing

Uses

Aids in the prevention of cavities.

Purpose

Anti-cavity toothpaste

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 physician
Do not swallow
To minimize wallowing, use a pea sizes amount in children under 6 years
Supervise children's brushing until good habits are established
Children under 2 years of age: consult a dentist or physician

Description

SODIUM FLUORIDE 0.24% (0.11 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>

Section 50565-1

Keep out of reach of children.

Section 51945-4

Active Ingredients

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

Inactive Ingredient

Sorbitol, Water, Silica, PEG-400, Sodium lauryl sulfate, Cellulose gum, Xanthan gum, flavor, Xylitol, Sodium sacharine, Sodium benzoate, Trisodium phosphate, CI 42090

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.

Do not use if the inner foil is torn, cut, or missing

Uses

Aids in the prevention of cavities.

Purpose

Anti-cavity toothpaste

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 physician
Do not swallow
To minimize wallowing, use a pea sizes amount in children under 6 years
Supervise children's brushing until good habits are established
Children under 2 years of age: consult a dentist or physician

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Active Ingredients (Active ingredients)

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

Inactive Ingredient (INACTIVE INGREDIENT)

Sorbitol, Water, Silica, PEG-400, Sodium lauryl sulfate, Cellulose gum, Xanthan gum, flavor, Xylitol, Sodium sacharine, Sodium benzoate, Trisodium phosphate, CI 42090

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM PHOSPHIDE", "unii": "A360RQX9W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Aids in the prevention of cavities.", "50565-1": "Keep out of reach of children.", "Purpose": "Anti-cavity toothpaste", "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. Do not use if the inner foil is torn, cut, or missing", "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 physician Do not swallow To minimize wallowing, use a pea sizes amount in children under 6 years Supervise children's brushing until good habits are established Children under 2 years of age: consult a dentist or physician", "Active ingredients": "SODIUM FLUORIDE 0.24% (0.11 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, Cellulose gum, Xanthan gum, flavor, Xylitol, Sodium sacharine, Sodium benzoate, Trisodium phosphate, CI 42090"}