5820091, 5820002 365 Everyday Value Cavity Fighting & Whitening Peppermint

5820091, 5820002 365 Everyday Value Cavity Fighting & Whitening Peppermint
SPL v10
SPL
SPL Set ID 83704717-19bc-2634-e053-2991aa0a2979
Route
DENTAL
Published
Effective Date 2019-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.13 g)
Inactive Ingredients
Benzyl Alcohol Glycerin Calcium Carbonate Xylitol Sodium Bicarbonate Carrageenan Zinc Citrate Hydrated Silica Sodium Lauroyl Sarcosinate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-03-06 Until 2025-11-21

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses aids in the prevention of dental caviites

Dosage and Administration

Directions

Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice per day, or as directed by a dentist or doctor.

  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • children under 2 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 under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients glycerin, water, calcium carbonate, hydrated silica, xylitol, sodium bicarbonate, carrageenan, sodium lauroyl sarcosinate, natural flavor, zinc citrate, benzyl alcohol

Section 53413-1

Questions or comments?

Section 55105-1

Purpose

Anticavity

Section 55106-9

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion) ...................... anticavity

Principal Display Panel


Structured Label Content

Indications and Usage (34067-9)

Uses aids in the prevention of dental caviites

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice per day, or as directed by a dentist or doctor.

  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • children under 2 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 under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients glycerin, water, calcium carbonate, hydrated silica, xylitol, sodium bicarbonate, carrageenan, sodium lauroyl sarcosinate, natural flavor, zinc citrate, benzyl alcohol

Section 53413-1 (53413-1)

Questions or comments?

Section 55105-1 (55105-1)

Purpose

Anticavity

Section 55106-9 (55106-9)

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion) ...................... anticavity

Principal Display Panel


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)