5820287 Signature Care Enamel Guard Sensitive Gentle Whitening

SPL v14

SPL

SPL Set ID 83222361-b89d-90e7-e053-2991aa0a7579

Route

DENTAL

Published

Effective Date 2019-03-02

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

Glycerin Water Saccharin Sodium Sorbitol Polyethylene Glycol, Unspecified Titanium Dioxide Sodium Hydroxide Xanthan Gum Hydrated Silica Cocamidopropyl Betaine

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-03-02

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

aids in the prevention of dental cavities
aids in reducing sensitivity

Dosage and Administration

Directions

Adults and children 12 years of age and older: Apply at least a 1-inch strip of the 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
Children under 12 years of age: consult a dentist or a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Store in a cool dry place

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 50566-9

Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50567-7

If pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

Section 51727-6

Inactive ingredients water, hydrated silica, sorbitol,glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

Section 51945-4

ALPINE MINT FLAVOR

Signature Care™ Enamel Guard

Gentle Whitening

DAILY ANTICAVITY TOOTHPASTE WITH FLUORIDE

HELPS HARDEN TOOTH ENAMEL WITH ACID PROTECTION FORMULA

NET WT 4 OZ (113 g)

Section 55105-1

Purpose

Antihypersensitivity

Anticavity

Section 55106-9

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.15% w/v fluoride ion

Structured Label Content

Indications and Usage (34067-9)

Uses

aids in the prevention of dental cavities
aids in reducing sensitivity

Dosage and Administration (34068-7)

Directions

Adults and children 12 years of age and older: Apply at least a 1-inch strip of the 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
Children under 12 years of age: consult a dentist or a doctor

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Store in a cool dry place

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 50566-9 (50566-9)

Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50567-7 (50567-7)

If pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

Section 51727-6 (51727-6)

Inactive ingredients water, hydrated silica, sorbitol,glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

Section 51945-4 (51945-4)

ALPINE MINT FLAVOR

Signature Care™ Enamel Guard

Gentle Whitening

DAILY ANTICAVITY TOOTHPASTE WITH FLUORIDE

HELPS HARDEN TOOTH ENAMEL WITH ACID PROTECTION FORMULA

NET WT 4 OZ (113 g)

Section 55105-1 (55105-1)

Purpose

Antihypersensitivity

Anticavity

Section 55106-9 (55106-9)

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.15% w/v fluoride ion

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses aids in the prevention of dental cavities aids in reducing sensitivity", "34068-7": "Directions Adults and children 12 years of age and older: Apply at least a 1-inch strip of the 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 Children under 12 years of age: consult a dentist or a doctor", "34071-1": "Warnings", "42229-5": "Drug Facts", "44425-7": "Store in a cool dry place", "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.", "50566-9": "Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.", "50567-7": "If pain/sensitivity still persists after 4 weeks of use, please visit your dentist.", "51727-6": "Inactive ingredients water, hydrated silica, sorbitol,glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide", "51945-4": "ALPINE MINT FLAVOR Signature Care™ Enamel Guard Gentle Whitening DAILY ANTICAVITY TOOTHPASTE WITH FLUORIDE HELPS HARDEN TOOTH ENAMEL WITH ACID PROTECTION FORMULA NET WT 4 OZ (113 g)", "55105-1": "Purpose Antihypersensitivity Anticavity", "55106-9": "Active ingredients Potassium nitrate 5% Sodium fluoride 0.15% w/v fluoride ion"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:13.128837 · Updated: 2026-03-14T23:10:28.026216