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

Purpose

Anticavity

Description

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

Medication Information

Warnings

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, glycerin, sodium lauryl sulfate, cellulose gum, flavor, tetrasodium pyrophosphate, sodium saccharin

Description

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

Questions?

1-800-468-6502

Use

helps protect against cavities

Section 42229-5

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

Active Ingredient

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

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

Warnings

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, glycerin, sodium lauryl sulfate, cellulose gum, flavor, tetrasodium pyrophosphate, sodium saccharin

Questions?

1-800-468-6502

Use

helps protect against cavities

Section 42229-5 (42229-5)

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

Active Ingredient

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

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