10g colgate + toothbrush + floss kit

10g colgate + toothbrush + floss kit
SPL v14
SPL
SPL Set ID ff75b8c7-1a70-4d06-a143-d51f4cabdf60
Route
dental
Published
Effective Date 2019-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (7.6 mg)
Inactive Ingredients
anhydrous dibasic calcium phosphate water sodium lauryl sulfate methyl salicylate carboxymethylcellulose sodium, unspecified form sodium pyrophosphate saccharin sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph final active Since 2018-06-07
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

Active Ingredient

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

Package Labeling:

Questions Or Comments?

Call to-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

Active Ingredient (Active ingredient)

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

Package Labeling:

Questions Or Comments? (Questions or comments?)

Call to-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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:22.862644 · Updated: 2026-03-14T23:00:47.249871