Dental Kits - Colgate Toothpaste

SPL v6

SPL

SPL Set ID f84217da-dc78-4181-9fcc-6b11e92276ff

Route

DENTAL

Published

Effective Date 2014-12-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (1.5 mg)

Inactive Ingredients

Calcium Phosphate, Dibasic, Dihydrate Water Sorbitol Sodium Lauryl Sulfate Sodium Pyrophosphate Saccharin Sodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2014-12-03

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

helps protect against cavities

Section 42229-5

Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022

Warnings

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

Questions?

1-800-468-6502

Active Ingredient

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

Inactive Ingredients

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

Drug Facts Panel Insert

Dental Kit Colgate Toothpaste 10g

TUBE LABELING:

KIT PACKAGING:

Dental Kit Colgate Toothpaste 5g Labels

TUBE LABELING:

KIT PACKAGING:

Keep Out of 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

Use

helps protect against cavities

Section 42229-5 (42229-5)

Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022

Purpose

Anticavity

Warnings

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

Questions?

1-800-468-6502

Active Ingredient

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

Inactive Ingredients

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

Drug Facts Panel Insert (DRUG FACTS PANEL INSERT)

Dental Kit Colgate Toothpaste 10g (DENTAL KIT - COLGATE TOOTHPASTE 10g)

TUBE LABELING:

KIT PACKAGING:

Dental Kit Colgate Toothpaste 5g Labels (DENTAL KIT - COLGATE TOOTHPASTE 5g Labels)

TUBE LABELING:

KIT PACKAGING:

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of 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

[{"name": "CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PYROPHOSPHATE", "unii": "O352864B8Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "1.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Use": "helps protect against cavities", "42229-5": "Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022", "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", "Questions?": "1-800-468-6502", "Active Ingredient": "Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)", "Inactive Ingredients": "dicalcium phosphate dihydrate, water, glycerin, sodium lauryl sulfate, cellulose gum, flavor, tetrasodium pyrophosphate, sodium saccharin", "DENTAL KIT - COLGATE TOOTHPASTE 10g": "TUBE LABELING: KIT PACKAGING:", "DENTAL KIT - COLGATE TOOTHPASTE 5g Labels": "TUBE LABELING: KIT PACKAGING:", "Keep out of 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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:54.158509 · Updated: 2026-03-14T23:00:05.624312