5820023 Natural Adult Fluoride

5820023 Natural Adult Fluoride
SPL v3
SPL
SPL Set ID a71c537e-39d9-1c3b-e053-2a95a90ac3ec
Route
DENTAL
Published
Effective Date 2020-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 g)
Inactive Ingredients
Carrageenan Glycerin Sodium Lauroyl Sarcosinate Water Xylitol Zinc Citrate Sodium Bicarbonate Calcium Carbonate Hydrated Silica Benzyl Alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-02

Description

Active ingredient Purpose Sodium monofluorophosphate 0/76% (0.13% w/v fluoride ion) . . . Anticavity


Medication Information

Description

Active ingredient Purpose Sodium monofluorophosphate 0/76% (0.13% w/v fluoride ion) . . . Anticavity

Uses

aids in the prevention of dental cavities

Section 50565-1

Keep out of reach of children under 6 years of age. If more than is swallowed for brushing si accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

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

Section 51945-4

Section 55106-9

Active ingredient Purpose

Sodium monofluorophosphate 0/76% (0.13% w/v fluoride ion) . . . Anticavity

Directions

adults and children 2 years of age and older: brush teeth thoroughly, 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.


Structured Label Content

Uses

aids in the prevention of dental cavities

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. If more than is swallowed for brushing si accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active ingredient Purpose

Sodium monofluorophosphate 0/76% (0.13% w/v fluoride ion) . . . Anticavity

Directions

adults and children 2 years of age and older: brush teeth thoroughly, 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.


Advanced Ingredient Data


Raw Label Data

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