colgate®

colgate®
SPL v3
SPL
SPL Set ID 75e1bd3b-a981-4cc3-ac92-b2e1383f0650
Route
dental
Published
Effective Date 2021-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.5 mg)
Inactive Ingredients
poloxamer 105 crospovidone, unspecified calcium pyrophosphate peg/ppg-116/66 copolymer hydrogen peroxide silicon dioxide sodium lauryl sulfate sodium pyrophosphate saccharin sodium sodium acid pyrophosphate sucralose butylated hydroxytoluene

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2021-11-23

Purpose

Anticavity

Description

Sodium Monofluorophosphate 1.14% (0.19% w/v fluoride ion)


Medication Information

Purpose

Anticavity

Directions
  • Adults and children 6 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 6 to 12 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
  • Children under 6 years: Do not use unless directed by a dentist or physician.
Inactive Ingredients

Poloxamer 105, PVP, Calcium Pyrophosphate, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (5% w/v), Silica, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

Description

Sodium Monofluorophosphate 1.14% (0.19% 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 U.S.A.

Section 50565-1

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.

Active Ingredient

Sodium Monofluorophosphate 1.14% (0.19% w/v fluoride ion)

Principal Display Panel 59 G Tube Label

Colgate®

Anticavity Fluoride Toothpaste

OPTIC

WHITE®

PRO SERIES

REMOVES

15 YEARS

OF STAINS*

5%

HYDROGEN

PEROXIDE

ENAMEL STRENGTH

NET WT 2.1 OZ (59 g)


Structured Label Content

Purpose

Anticavity

Directions
  • Adults and children 6 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 6 to 12 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
  • Children under 6 years: Do not use unless directed by a dentist or physician.
Inactive Ingredients (Inactive ingredients)

Poloxamer 105, PVP, Calcium Pyrophosphate, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (5% w/v), Silica, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

Questions?

1-800-468-6502

Use

helps protect against cavities

Section 42229-5 (42229-5)

Dist. by:

COLGATE-PALMOLIVE COMPANY

New York, NY 10022 U.S.A.

Section 50565-1 (50565-1)

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.

Active Ingredient (Active ingredient)

Sodium Monofluorophosphate 1.14% (0.19% w/v fluoride ion)

Principal Display Panel 59 G Tube Label (PRINCIPAL DISPLAY PANEL - 59 g Tube Label)

Colgate®

Anticavity Fluoride Toothpaste

OPTIC

WHITE®

PRO SERIES

REMOVES

15 YEARS

OF STAINS*

5%

HYDROGEN

PEROXIDE

ENAMEL STRENGTH

NET WT 2.1 OZ (59 g)


Advanced Ingredient Data


Raw Label Data

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