5820056 Ra Gum Purify

5820056 Ra Gum Purify
SPL v7
SPL
SPL Set ID ccad4383-4479-6175-e053-2a95a90a13a2
Route
DENTAL
Published
Effective Date 2021-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.14 g)
Inactive Ingredients
Saccharin Sodium Water Sodium Lauryl Sulfate Carrageenan Titanium Dioxide Sorbitol Hydrated Silica Xanthan Gum Sodium Hydroxide Zinc Citrate Sucralose

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-10 Until 2027-01-01
Description

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

Medication Information

Indications and Usage

aids in the prevention of cavities * helps prevent gingivitis * helps interfere with the harmful effects of plaque associated with gingivitis * helps control plaque bacteria that contribute to the development of gingivitis

Dosage and Administration

adults and children 12 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist of physician * do not swallow * children under 12 years of age: ask a dentist

Description

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

Section 50565-1

Keep out of reach of children under 12 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

water, hydrated silica, sorbitol, sodium lauryl sulfate, carrageenan, flavor, xanthan gum, zinc citrate, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide

Section 51945-4

Section 55105-1

Anticavity/Antigingivitis

Section 55106-9

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

Section 60561-8

products containing 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 * see your dentist regularly

Structured Label Content

Indications and Usage (34067-9)

aids in the prevention of cavities * helps prevent gingivitis * helps interfere with the harmful effects of plaque associated with gingivitis * helps control plaque bacteria that contribute to the development of gingivitis

Dosage and Administration (34068-7)

adults and children 12 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist of physician * do not swallow * children under 12 years of age: ask a dentist

Section 50565-1 (50565-1)

Keep out of reach of children under 12 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)

water, hydrated silica, sorbitol, sodium lauryl sulfate, carrageenan, flavor, xanthan gum, zinc citrate, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity/Antigingivitis

Section 55106-9 (55106-9)

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

Section 60561-8 (60561-8)

products containing 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 * see your dentist regularly

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:13.210682 · Updated: 2026-03-14T23:10:28.026216