Colgate®

Colgate®
SPL v2
SPL
SPL Set ID 133acaff-7205-80d7-e91d-3eb37087cae4
Route
DENTAL
Published
Effective Date 2022-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Glycerin Propylene Glycol Sorbitol Poloxamer 407 Poloxamer 338 Peg-40 Castor Oil Phosphoric Acid Saccharin Sodium Sodium Phosphate, Dibasic, Unspecified Form Potassium Sorbate Cetylpyridinium Chloride Sucralose Fd&c Green No. 3 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-05

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

aids in the prevention of dental cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervison

Children under 6 years of age: consult a dentist or doctor

Questions?

1-800-468-6502

Active Ingredient

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Other Information

Store at controlled room temperature 68 – 77° F (20 – 25°C)

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Poloxamer 338, Flavor, PEG-40 Hydrogenated Castor Oil, Phosphoric Acid, Sodium Saccharin, Disodium Phosphate, Potassium Sorbate, Cetylpyridinium Chloride, Sucralose, Green 3, Red 33.

Principal Display Panel 500 Ml Bottle Label

ALCOHOL FREE

Colgate®

Anticavity Fluoride Rinse

Kids

  • Strengthens

    Enamel
  • Protects from

    Cavities
  • Cleans the

    Whole Mouth*

16.9 FL OZ

(1.05 PT) 500 mL

BUBBLE FRUIT®

IMPORTANT: Read directions for proper use

PS0029450


Structured Label Content

Use

aids in the prevention of dental cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Anticavity

Directions

Adults and children 6 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervison

Children under 6 years of age: consult a dentist or doctor

Questions?

1-800-468-6502

Active Ingredient (Active ingredient)

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Other Information (Other information)

Store at controlled room temperature 68 – 77° F (20 – 25°C)

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Poloxamer 338, Flavor, PEG-40 Hydrogenated Castor Oil, Phosphoric Acid, Sodium Saccharin, Disodium Phosphate, Potassium Sorbate, Cetylpyridinium Chloride, Sucralose, Green 3, Red 33.

Principal Display Panel 500 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label)

ALCOHOL FREE

Colgate®

Anticavity Fluoride Rinse

Kids

  • Strengthens

    Enamel
  • Protects from

    Cavities
  • Cleans the

    Whole Mouth*

16.9 FL OZ

(1.05 PT) 500 mL

BUBBLE FRUIT®

IMPORTANT: Read directions for proper use

PS0029450


Advanced Ingredient Data


Raw Label Data

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