5820079 Walmart Equate Schulpted White (80-15271)

5820079 Walmart Equate Schulpted White (80-15271)
SPL v5
SPL
SPL Set ID 1e647d52-9f87-2278-e063-6394a90aafa0
Route
ORAL
Published
Effective Date 2024-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.15 g)
Inactive Ingredients
Sorbitol Sodium Acid Pyrophosphate Carboxymethylcellulose Sodium Carboxypolymethylene Fd&c Blue No. 1 Mica Titanium Dioxide Water Hydrated Silica Saccharin Sodium Sodium Hydroxide Sodium Lauryl Sulfate

Identifiers & Packaging

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

Description

Sodium fluoride 0.243% (0.15% w/v fluoride ion)


Medication Information

Warnings and Precautions

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.

Indications and Usage

aids in the prevention of dental cavities

Dosage and Administration

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 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

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

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

water, sorbitol, hydrated silica, disodium pyrophosphate, flavor, sodium lauryl sulfate, cellulose gum, sodium hydroxide, sodium saccharin, carbomer, mica, titanium dioxide, blue 1

Section 51945-4

Section 55105-1

Anticavity

Section 55106-9

Sodium fluoride 0.243% (0.15% w/v fluoride ion)


Structured Label Content

Indications and Usage (34067-9)

aids in the prevention of dental cavities

Dosage and Administration (34068-7)

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 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)

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 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)

water, sorbitol, hydrated silica, disodium pyrophosphate, flavor, sodium lauryl sulfate, cellulose gum, sodium hydroxide, sodium saccharin, carbomer, mica, titanium dioxide, blue 1

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Sodium fluoride 0.243% (0.15% w/v fluoride ion)


Advanced Ingredient Data


Raw Label Data

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