5820077 Walmart Equate Optimal Care (80-15077)

5820077 Walmart Equate Optimal Care (80-15077)
SPL v5
SPL
SPL Set ID 1e65b83e-a51a-4adb-e063-6394a90a06b4
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
Propylene Glycol Hydrated Silica Polyethylene Glycol 12000 Sodium Hydroxide Xanthan Gum Saccharin Sodium Anhydrous Trisodium Citrate Glycerin Anhydrous Citric Acid Titanium Dioxide Sodium Lauryl Sulfate Sodium Pyrophosphate Carboxymethylcellulose Sodium Sucralose Sorbitol Cocamidopropyl Betaine Water Zinc Lactate

Identifiers & Packaging

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

Description

Stannous fluoride 0.454% (0.15% 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 • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. • pain/sensitivity still persists after 4 weeks of use.

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% (0.15% w/v fluoride ion)

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 51727-6

water, hydrated silica, sorbitol, glycerin, PEG-12, tetrasodium pyrophosphate, sodium lauryl sulfate, flavor, sodium citrate, zinc lactate, cellulose gum, sodium saccharin, cocamidopropyl betaine, propylene glycol, xanthan gum, citric acid, sucralose, titanium dioxide, sodium hydroxide

Section 51945-4

Section 55105-1

Anticavity, antigingivitis, antisensitivity

Section 55106-9

Stannous fluoride 0.454% (0.15% 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 • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. • pain/sensitivity still persists after 4 weeks of 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 51727-6 (51727-6)

water, hydrated silica, sorbitol, glycerin, PEG-12, tetrasodium pyrophosphate, sodium lauryl sulfate, flavor, sodium citrate, zinc lactate, cellulose gum, sodium saccharin, cocamidopropyl betaine, propylene glycol, xanthan gum, citric acid, sucralose, titanium dioxide, sodium hydroxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity, antigingivitis, antisensitivity

Section 55106-9 (55106-9)

Stannous fluoride 0.454% (0.15% w/v fluoride ion)


Advanced Ingredient Data


Raw Label Data

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