colgate anticavity toothpaste

colgate anticavity toothpaste
SPL v2
SPL
SPL Set ID b1a41464-e7d7-640c-e053-2995a90a3f95
Route
dental
Published
Effective Date 2020-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2020-10-15
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)

Questions Or Comments?

Call toll-free 1-800-468-6502

Package Labeling:69491 033 01

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)

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-468-6502

Package Labeling:69491 033 01 (Package Labeling:69491-033-01)

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: 2026-02-15T12:00:28.703886 · Updated: 2026-03-14T23:00:54.830446