quip anticavity fluoride mouthwash concentrate

quip anticavity fluoride mouthwash concentrate
SPL v3
SPL
SPL Set ID b3da65bb-0871-34e7-e053-2a95a90a310e
Route
dental
Published
Effective Date 2020-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.05 g)
Inactive Ingredients
edetate disodium anhydrous erythritol water polysorbate 20 xylitol sodium hydroxide sucralose cetylpyridinium chloride

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
otc monograph drug active Since 2021-01-25

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredient (diluted solution)

0.05% Sodium fluoride (0.02% w/v fluoride ion)

Indications and Usage

Use

Aids in prevention of dental cavities

Dosage and Administration

Directions

  • Do not use before mixing with water
  • Measure 2.5ml. Dilute with water to 4x volume (10ml). Use immediately
  • Adults and children 6 years of age and older:
  • Use once a day after brushing your teeth with a toothpaste
  • Vigorously swish 10ml 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
  • Supervise children as necessary until capable of using without supervision
  • Children under 6 years of age:consult a dentist or doctor
Description

Drug Facts

Bottle

Anticavity Fluoride Mouthwash Refill

Mint


CONCENTRATE 4x470mL DILUTED

QUIP

117.5 ML (3.97 FL OZ)

IMPORTANT:Read directions for proper use

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • Do not store the diluted product
  • Store concentrate at room temperature
  • Do not use if seal under cap is broken or missing.
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.

Section 51727-6

Inactive ingredients

Water, Xylitol, Erythritol, Polysorbate 20, Flavor, Sucralose, Disodium EDTA, Cetylpyridinium Chloride, Sodium Hydroxide

Section 55105-1

Purpose

Anticavity

Starter Kit

QUIP

MouthwashStarter Kit

Refillable Dispenser & Cup

One pump for perfect daily dose

Mint Anticavity Fluoride Mouthwash Refill

Kills bad breath germs

Freshens breath

Strengthens teeth

Helps prevent cavities

Alcohol-free formula

Vegan-friendly

4XCONCENTRATE 470mL DILUTED

117.5 ML (3.97 FL OZ)

IMPORTANT: Read directions for proper use

Retail Carton

QUIP

CONCENTRATE 4x470mL DILUTED

  • Kills bad breath germs
  • Freshens breath
  • Strengthens teeth
  • Helps prevent cavities
  • Alcohol-free formula
  • Vegan-friendly

Anticavity Fluoride Mouthwash Refill

Mint


117.5 ML (3.97 FL OZ)

IMPORTANT: Read directions for proper use


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredient (diluted solution)

0.05% Sodium fluoride (0.02% w/v fluoride ion)

Indications and Usage (34067-9)

Use

Aids in prevention of dental cavities

Dosage and Administration (34068-7)

Directions

  • Do not use before mixing with water
  • Measure 2.5ml. Dilute with water to 4x volume (10ml). Use immediately
  • Adults and children 6 years of age and older:
  • Use once a day after brushing your teeth with a toothpaste
  • Vigorously swish 10ml 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
  • Supervise children as necessary until capable of using without supervision
  • Children under 6 years of age:consult a dentist or doctor
Bottle (BOTTLE)

Anticavity Fluoride Mouthwash Refill

Mint


CONCENTRATE 4x470mL DILUTED

QUIP

117.5 ML (3.97 FL OZ)

IMPORTANT:Read directions for proper use

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • Do not store the diluted product
  • Store concentrate at room temperature
  • Do not use if seal under cap is broken or missing.
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.

Section 51727-6 (51727-6)

Inactive ingredients

Water, Xylitol, Erythritol, Polysorbate 20, Flavor, Sucralose, Disodium EDTA, Cetylpyridinium Chloride, Sodium Hydroxide

Section 55105-1 (55105-1)

Purpose

Anticavity

Starter Kit (STARTER KIT)

QUIP

MouthwashStarter Kit

Refillable Dispenser & Cup

One pump for perfect daily dose

Mint Anticavity Fluoride Mouthwash Refill

Kills bad breath germs

Freshens breath

Strengthens teeth

Helps prevent cavities

Alcohol-free formula

Vegan-friendly

4XCONCENTRATE 470mL DILUTED

117.5 ML (3.97 FL OZ)

IMPORTANT: Read directions for proper use

Retail Carton (RETAIL CARTON)

QUIP

CONCENTRATE 4x470mL DILUTED

  • Kills bad breath germs
  • Freshens breath
  • Strengthens teeth
  • Helps prevent cavities
  • Alcohol-free formula
  • Vegan-friendly

Anticavity Fluoride Mouthwash Refill

Mint


117.5 ML (3.97 FL OZ)

IMPORTANT: Read directions for proper use


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)