5820230, 5820273 Heb Sensitive Restore And Defend

5820230, 5820273 Heb Sensitive Restore And Defend
SPL v14
SPL
SPL Set ID 56080493-9ab8-4b4f-be5f-7df22dee133f
Route
DENTAL
Published
Effective Date 2025-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.15 g)
Inactive Ingredients
Sorbitol Glycerin Saccharin Sodium Water Titanium Dioxide Sodium Tripolyphosphate Anhydrous Carboxymethylcellulose Sodium Cocamidopropyl Betaine Sodium Lauryl Sulfate Hydrated Silica

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-07-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • aids in the prevention of dental cavities
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids sweets or contact
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 directed by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
  • Do not swallow.
  • Children under 12 years of age: consult a dentist or doctor.
Description

Drug Facts

Section 42229-5

Drug Facts

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.
  • pain/sensitivity still persists after 4 weeks of use
Section 50567-7

When using this product, if irritation occurs discontinue use.

Section 51727-6

Inactive ingredients glycerin, water, hydrated silica, pentasodium triphosphate, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin

Section 51945-4

Section 53413-1

Questions or Comments? CALL 1-877-777-2743

Section 55105-1

Purpose

Anticavity/Antihypersensitivity

Section 55106-9

Active ingredients

Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

Section 60561-8

Other information products containng stannous fluoride may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

  • this product is specifically formulated to help prevent staining.

Structured Label Content

Indications and Usage (34067-9)

Uses

  • aids in the prevention of dental cavities
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids sweets or contact
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 directed by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
  • Do not swallow.
  • Children under 12 years of age: consult a dentist or doctor.
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

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.
  • pain/sensitivity still persists after 4 weeks of use
Section 50567-7 (50567-7)

When using this product, if irritation occurs discontinue use.

Section 51727-6 (51727-6)

Inactive ingredients glycerin, water, hydrated silica, pentasodium triphosphate, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments? CALL 1-877-777-2743

Section 55105-1 (55105-1)

Purpose

Anticavity/Antihypersensitivity

Section 55106-9 (55106-9)

Active ingredients

Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

Section 60561-8 (60561-8)

Other information products containng stannous fluoride may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

  • this product is specifically formulated to help prevent staining.

Advanced Ingredient Data


Raw Label Data

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