5820082 Target Whitening Toothpaste (8070491)

5820082 Target Whitening Toothpaste (8070491)
SPL v6
SPL
SPL Set ID 0074630f-9d8d-9209-e063-6294a90a4f01
Route
DENTAL
Published
Effective Date 2023-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.14 g)
Inactive Ingredients
Sorbitol Sodium Hydroxide Potassium Sorbate Hydrated Silica Sucralose Sorbic Acid Water Glycerin Titanium Dioxide Sodium Lauryl Sulfate Cocamidopropyl Betaine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-02-10 Until 2025-01-24

Description

Sodium monofluorophosphate 0.76% w/w (0.14% w/v fluoride ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium monofluorophosphate 0.76% w/w (0.14% w/v fluoride ion)

Uses

aids in the prevention of dental cavities

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years of age and older: brush teeth thoroughly, preferably after ach meal or at least twice per day, or as directed by a dentist or doctor.

instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

supervise children as necessary until capable of using without supervision.

children under 2 years of age: Consult a dentist or doctor.

Active Ingredient

Sodium monofluorophosphate 0.76% w/w (0.14% w/v fluoride ion)

Inactive Ingredients

glycerin, hydrated silica, water, sorbitol, pentasodium triphosphate, PVP, titanium dioxide, cellulose gum, flavor, cocamidopropyl betaine, sodium lauryl sulfate, potassium sorbate, sorbic acid, potassium acesulfam, sucralose, sodium hydroxide

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

aids in the prevention of dental cavities

Purpose

Anticavity

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years of age and older: brush teeth thoroughly, preferably after ach meal or at least twice per day, or as directed by a dentist or doctor.

instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

supervise children as necessary until capable of using without supervision.

children under 2 years of age: Consult a dentist or doctor.

Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76% w/w (0.14% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

glycerin, hydrated silica, water, sorbitol, pentasodium triphosphate, PVP, titanium dioxide, cellulose gum, flavor, cocamidopropyl betaine, sodium lauryl sulfate, potassium sorbate, sorbic acid, potassium acesulfam, sucralose, sodium hydroxide

Principal Display Panel

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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