5820269 Heb Enamel Protection Multi-action Sensitive Toothpaste

5820269 Heb Enamel Protection Multi-action Sensitive Toothpaste
SPL v14
SPL
SPL Set ID 8255de83-aa60-b081-e053-2a91aa0afcdc
Route
DENTAL
Published
Effective Date 2025-11-21
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
Saccharin Sodium Water Sorbitol Titanium Dioxide Sodium Hydroxide Glycerin Xanthan Gum Hydrated Silica Cocamidopropyl Betaine Mica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-20

Description

Drug Facts


Medication Information

Warnings and Precautions

When using this product, if irritation occurs discontinue use.

Indications and Usage

Uses

  • builds increasing protection against painful sensitivity of the teeth
  • aids in the prevention of dental cavities
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
  • Minimize swallowing.
  • Spit out after brushing.

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. Keep tube capped when not in use.

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 see your 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 51727-6

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

Section 51945-4

Section 53413-1

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

Section 55105-1

Purpose

Antihypersensitivity

Anticavity

Section 55106-9

Active ingredients

Potassium nitrate 5%

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


Structured Label Content

Indications and Usage (34067-9)

Uses

  • builds increasing protection against painful sensitivity of the teeth
  • aids in the prevention of dental cavities
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
  • Minimize swallowing.
  • Spit out after brushing.

Children under 12 years of age: Consult a dentist or a doctor.

Warnings and Precautions (34071-1)

When using this product, if irritation occurs discontinue use.

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

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

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 see your 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 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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

Section 55105-1 (55105-1)

Purpose

Antihypersensitivity

Anticavity

Section 55106-9 (55106-9)

Active ingredients

Potassium nitrate 5%

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


Advanced Ingredient Data


Raw Label Data

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