5820184 Topco Max Str Sens Mint

5820184 Topco Max Str Sens Mint
SPL v9
SPL
SPL Set ID ac398ff0-0010-4e13-8b89-dc986fd7f974
Route
DENTAL
Published
Effective Date 2012-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.15 g) Nitrate Ion (5 g)
Inactive Ingredients
Water Saccharin Sodium Sodium Phosphate, Tribasic Sorbitol Titanium Dioxide Glycerin Xanthan Gum Hydrated Silica Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-01-20 Until 2028-06-26

Description

Potassium nitrate 5%....................................................Antihypersensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

Purpose

Potassium nitrate 5%....................................................Antihypersensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity


Medication Information

Warnings and Precautions

If pain/sensitivity still persists after 4 weeks of use, please visit your dentist. Stop use and see your doctor if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Purpose

Potassium nitrate 5%....................................................Antihypersensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

Dosage and Administration

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.

Description

Potassium nitrate 5%....................................................Antihypersensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

Uses

aids in the prevention of dental cavities

Section 50565-1

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

Section 51945-4

Directions

Adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush. Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive Ingredients

cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

Active Ingredients / Purpose

Potassium nitrate 5%....................................................Antihypersensitivity

Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity


Structured Label Content

Uses

aids in the prevention of dental cavities

Dosage and Administration (34068-7)

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.

Warnings and Precautions (34071-1)

If pain/sensitivity still persists after 4 weeks of use, please visit your dentist. Stop use and see your doctor if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Directions

Adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush. Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive Ingredients (Inactive ingredients)

cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

Active Ingredients / Purpose (Active ingredients / Purpose)

Potassium nitrate 5%....................................................Antihypersensitivity

Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity


Advanced Ingredient Data


Raw Label Data

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