5820078 Walmart Equate Pro-advanced (80-15078)

5820078 Walmart Equate Pro-advanced (80-15078)
SPL v5
SPL
SPL Set ID 1e6561fb-4e3b-40ba-e063-6294a90a2690
Route
ORAL
Published
Effective Date 2024-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.16 g)
Inactive Ingredients
Saccharin Sodium Zinc Lactate Glycerin Polyethylene Glycol 300 Xanthan Gum Fd&c Blue No. 1 Water Carrageenan Hydrated Silica Propylene Glycol Cocamidopropyl Betaine Sodium Lauryl Sulfate Sodium Polymetaphosphate Sodium Phosphate, Tribasic, Anhydrous Povidone Sodium Gluconate

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-18

Description

Stannous fluoride 0.454% (0.16% w/v fluoride ion)


Medication Information

Warnings and Precautions

when using this product, if irritation occurs discontinue use.

Stop use and ask a dentist if if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivty still persists after 4 weeks of use.

Keep out of reach or children.

Indications and Usage

aids in the prevention of cavities

helps prevent gingivitis

helps interfere with the harmful effects of plaque associated with gingivitis

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

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 twice a day (morning and evening) or as recommended by a dentist.

Make sure to brush all sensitive areas of the teeth. Do not swallow. • children under 12 years of age: Consult a dentist

Description

Stannous fluoride 0.454% (0.16% w/v fluoride ion)

Section 50565-1

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get meedical help or contact a Poison Control Center right away.

Section 51727-6

glycerin, hydrated silica, sodium hexametaphosphate, water, propylene glycol, PEG-8, zinc lactate, flavor, sodium lauryl sulfate, sodium gluconate, sodium saccharin, trisodium phosphate, xanthan gum, PVP, carrageenan, cocamidopropyl betaine, blue 1

Section 51945-4

Section 55105-1

Anticavity, antigingivitis, antisensitivity

Section 55106-9

Stannous fluoride 0.454% (0.16% w/v fluoride ion)


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

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

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 twice a day (morning and evening) or as recommended by a dentist.

Make sure to brush all sensitive areas of the teeth. Do not swallow. • children under 12 years of age: Consult a dentist

Warnings and Precautions (34071-1)

when using this product, if irritation occurs discontinue use.

Stop use and ask a dentist if if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivty still persists after 4 weeks of use.

Keep out of reach or children.

Section 50565-1 (50565-1)

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get meedical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

glycerin, hydrated silica, sodium hexametaphosphate, water, propylene glycol, PEG-8, zinc lactate, flavor, sodium lauryl sulfate, sodium gluconate, sodium saccharin, trisodium phosphate, xanthan gum, PVP, carrageenan, cocamidopropyl betaine, blue 1

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity, antigingivitis, antisensitivity

Section 55106-9 (55106-9)

Stannous fluoride 0.454% (0.16% w/v fluoride ion)


Advanced Ingredient Data


Raw Label Data

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