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SPL v2
SPL
SPL Set ID fb6c355b-a67d-c4b4-e053-6394a90a0e66
Route
dental
Published
Effective Date 2023-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.5 mg)
Inactive Ingredients
dibasic calcium phosphate dihydrate water sorbitol sodium lauryl sulfate carboxymethylcellulose sodium, unspecified form sodium pyrophosphate saccharin sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2023-06-01

Purpose

Anticavity

Description

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)


Medication Information

Purpose

Anticavity

Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask a dentist or physician

Inactive Ingredients

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Description

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Use

helps protect against cavities

Drug Facts

Active Ingredient

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Package Labeling;

Questions Or Comments?

Call toll-free 1-800-468-6502

Package Labeling:42555 060 94

Keep Out of the 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.


Structured Label Content

Purpose

Anticavity

Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask a dentist or physician

Inactive Ingredients (Inactive ingredients)

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Use

helps protect against cavities

Drug Facts

Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Package Labeling;

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-468-6502

Package Labeling:42555 060 94 (Package Labeling:42555-060-94)

Keep Out of the Reach of Children Under 6 Years of Age. (Keep out of the 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.


Advanced Ingredient Data


Raw Label Data

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