Colgate 5g Toothpaste And Toothbrush Dental Kit

Colgate 5g Toothpaste And Toothbrush Dental Kit
SPL v7
SPL
SPL Set ID 0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13
Route
DENTAL
Published
Effective Date 2021-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Dibasic Calcium Phosphate Dihydrate Methyl Salicylate Sodium Lauryl Sulfate Saccharin Sodium Sorbitol Sodium Pyrophosphate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-19
Description

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

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

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

Use

Aids in the prevention of dental caries

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 doctor. Instruct children under 6 years of age in good brushing and rinising habits (to minimize swallowing). Supervuse children as necessary until capable of using without supervision.
  • Children under 6 years of age: Consult a dentist or doctor.
Active Ingredient

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

Package Labeling:5g

Inactive Ingredients

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

Package Labeling:kit

Questions Or Comments?

1-800-468-6502

Keep Out of Reach of Children.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Use

Aids in the prevention of dental caries

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 doctor. Instruct children under 6 years of age in good brushing and rinising habits (to minimize swallowing). Supervuse children as necessary until capable of using without supervision.
  • Children under 6 years of age: Consult a dentist or doctor.
Active Ingredient (Active ingredient)

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

Package Labeling:5g

Inactive Ingredients (Inactive ingredients)

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

Package Labeling:kit (Package Labeling:Kit)

Questions Or Comments? (Questions or comments?)

1-800-468-6502

Keep Out of Reach of Children. (Keep out of reach of children.)

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: 2026-02-15T12:08:26.309190 · Updated: 2026-03-14T23:12:38.341862