5820169 heb sensitive extra whitening toothpaste

5820169 heb sensitive extra whitening toothpaste
SPL v14
SPL
SPL Set ID b76c3591-6383-4661-b3db-7a56b11202f7
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) nitrate ion (5 g)
Inactive Ingredients
water saccharin sodium sodium tripolyphosphate polyethylene glycol 400 sorbitol titanium dioxide sodium hydroxide glycerin xanthan gum hydrated silica cocamidopropyl betaine sodium methyl cocoyl taurate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2011-01-20

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

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

Active Ingredient

Active ingredients

Potassium nitrate 5%

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

Indications and Usage

Uses

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • 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 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 ask a dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Section 51727-6

Inactive ingredients

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

Section 51945-4

Section 53413-1

Questions or Comments? CALL 1-877-777-2748

Section 55105-1

Purpose

Antihypersensitivity

Anticavity


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

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

Active Ingredient (55106-9)

Active ingredients

Potassium nitrate 5%

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

Indications and Usage (34067-9)

Uses

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • 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 doctor.
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 ask a dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments? CALL 1-877-777-2748

Section 55105-1 (55105-1)

Purpose

Antihypersensitivity

Anticavity


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)