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
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 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.
Inactive Ingredients

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

Description

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

Use

Aids in the prevention of dental caries

Active Ingredient

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

Package Labeling:5g

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

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.
Inactive Ingredients (Inactive ingredients)

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

Use

Aids in the prevention of dental caries

Active Ingredient (Active ingredient)

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

Package Labeling:5g

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

Back to search View SPL set listing Open on DailyMed ↗

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