Just Right 5000 - Bubble Mint

Just Right 5000 - Bubble Mint
SPL v6
SPL
SPL Set ID 5aa80253-a756-26fc-e053-2a91aa0adc23
Route
TOPICAL
Published
Effective Date 2018-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 g)
Inactive Ingredients
Water Sorbitol Hydrated Silica Glycerin Fd&c Blue No. 1 Saccharin Potassium Phosphate, Monobasic Xanthan Gum

Identifiers & Packaging

Pill Appearance
Shape: round Color: blue
Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-01-01

Description

Sodium Fluoride 1.1% Anticavity toothpaste

Purpose

Helps protect against Cavities


Medication Information

Purpose

Helps protect against Cavities

Description

Sodium Fluoride 1.1% Anticavity toothpaste

Warnings Section

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.

Otc Purpose Section

Helps protect against Cavities

Otc Questions Section

Questions? 1-877-866-9113 or visit our website at www.elevateoralcare.com

Inactive Ingredient Section

Inactive ingredients; Sorbitol, Water, Glycerin, Hydrated silica, PEG-8, Bubble Gum/Mint Flavor, Sodium Lauryl Sulfate, Xanthan Gum, Potassium Phosphate, Sodium Benzoate, Sodium Saccharin, Mica, Blue 1.1% Solution

Indications & Usage Section

helps protect against cavities

Instructions for Use Section

Directions: *adults and children 2 years and older: wet a toothbrush and pump once to apply a pea-sized (~0.25 gram) amount of toothpaste onto a toothbrush * brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. * to minimize swallowing, only pump once to dispense a pea-sized amount for children under 6 years. * supervise children's brushing untill good habits are established. * children under 2 years: ask dentist or physician.

Dosage & Administration Section

Directions: *adults and children 2 years and older: wet a toothbrush and pump once to apply a pea-sized (~0.25 gram) amount of toothpaste onto a toothbrush * brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. * to minimize swallowing, only pump once to dispense a pea-sized amount for children under 6 years. * supervise children's brushing untill good habits are established. * children under 2 years: ask dentist or physician.

Otc Active Ingredient Section

Sodium Fluoride 1.1% Anticavity toothpaste

Package Label.principal Display Panel

Otc Keep Out of Reach of Children Section

Keep out of reach of children under 6 years of age:


Structured Label Content

Warnings Section (WARNINGS SECTION)

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.

Otc Purpose Section (OTC - PURPOSE SECTION)

Helps protect against Cavities

Otc Questions Section (OTC - QUESTIONS SECTION)

Questions? 1-877-866-9113 or visit our website at www.elevateoralcare.com

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive ingredients; Sorbitol, Water, Glycerin, Hydrated silica, PEG-8, Bubble Gum/Mint Flavor, Sodium Lauryl Sulfate, Xanthan Gum, Potassium Phosphate, Sodium Benzoate, Sodium Saccharin, Mica, Blue 1.1% Solution

Indications & Usage Section (INDICATIONS & USAGE SECTION)

helps protect against cavities

Instructions for Use Section (INSTRUCTIONS FOR USE SECTION)

Directions: *adults and children 2 years and older: wet a toothbrush and pump once to apply a pea-sized (~0.25 gram) amount of toothpaste onto a toothbrush * brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. * to minimize swallowing, only pump once to dispense a pea-sized amount for children under 6 years. * supervise children's brushing untill good habits are established. * children under 2 years: ask dentist or physician.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: *adults and children 2 years and older: wet a toothbrush and pump once to apply a pea-sized (~0.25 gram) amount of toothpaste onto a toothbrush * brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. * to minimize swallowing, only pump once to dispense a pea-sized amount for children under 6 years. * supervise children's brushing untill good habits are established. * children under 2 years: ask dentist or physician.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Sodium Fluoride 1.1% Anticavity toothpaste

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children under 6 years of age:


Advanced Ingredient Data


Raw Label Data

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