colgate®

colgate®
SPL v8
SPL
SPL Set ID c4a050a6-601e-467b-a0b0-5b21035bdb07
Route
dental
Published
Effective Date 2019-04-02
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 potassium sorbate cetylpyridinium chloride saccharin sodium sucralose poloxamer 407 poloxamer 338 sodium phosphate, dibasic, anhydrous peg-40 castor oil phosphoric acid fd&c blue no. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
otc monograph drug active Since 2015-08-01

Purpose

Anticavity

Description

Drug Facts


Medication Information

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 supervision

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

Other Information

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

Inactive Ingredients

water, glycerin, propylene glycol, sorbitol, poloxamer 338, poloxamer 407, flavor, PEG-40 castor oil, phosphoric acid, sodium saccharin, disodium phosphate, potassium sorbate, cetylpyridinium chloride, sucralose, FD&C blue no. 1

Description

Drug Facts

Questions?

1-800-468-6502

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.

Active Ingredient

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

Principal Display Panel 500 Ml Bottle Label

NEW

ALCOHOL FREE

Colgate ®

Kids Anticavity Fluoride Rinse

ILLUMINATION

ENTERTAINMENT

minions

16.9 FL OZ

(1.05 PT) 500 mL

P9902670

BELLO™ BUBBLE FRUIT®

IMPORTANT: Read directions for proper use


Structured Label Content

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 supervision

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

Other Information

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

Inactive Ingredients (Inactive ingredients)

water, glycerin, propylene glycol, sorbitol, poloxamer 338, poloxamer 407, flavor, PEG-40 castor oil, phosphoric acid, sodium saccharin, disodium phosphate, potassium sorbate, cetylpyridinium chloride, sucralose, FD&C blue no. 1

Questions?

1-800-468-6502

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.

Active Ingredient (Active ingredient)

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

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

NEW

ALCOHOL FREE

Colgate ®

Kids Anticavity Fluoride Rinse

ILLUMINATION

ENTERTAINMENT

minions

16.9 FL OZ

(1.05 PT) 500 mL

P9902670

BELLO™ BUBBLE FRUIT®

IMPORTANT: Read directions for proper use


Advanced Ingredient Data


Raw Label Data

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