united asutra tc kit colgate toothpaste

united asutra tc kit colgate toothpaste
SPL v1
SPL
SPL Set ID 082a581a-c7e5-e614-e063-6394a90a87da
Route
dental
Published
Effective Date 2023-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2023-08-07

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:

Package Labeling:kit

Questions Or Comments?

Call toll-free 1-800-468-6502

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:

Package Labeling:kit (Package Labeling:Kit)

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-468-6502

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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