QUIP ANTICAVITY FLUORIDE CONCENTRATE- sodium fluoride mouthwash

Quip Anticavity Fluoride by

Drug Labeling and Warnings

Quip Anticavity Fluoride by is a Otc medication manufactured, distributed, or labeled by Quip NYC Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (diluted solution)

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

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Use

Aids in prevention of dental cavities

WARNINGS

Warnings

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & 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

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

Distributed by: quip NYC Inc., 45 Main Street, Brooklyn, NY 11201, USA

Questions? hello@getquip.com

BOTTLE

Anticavity Fluoride Mouthwash Refill
Mint
CONCENTRATE 4x 470mL DILUTED
QUIP
117.5 ML (3.97 FL OZ)

IMPORTANT: Read directions for proper use

RETAIL CARTON

QUIP

CONCENTRATE 4x 470mL 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

STARTER KIT

QUIP

Mouthwash Starter 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

4X CONCENTRATE 470mL DILUTED

117.5 ML (3.97 FL OZ)
IMPORTANT: Read directions for proper use

INGREDIENTS AND APPEARANCE

QUIP ANTICAVITY FLUORIDE  CONCENTRATE
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69261-005
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ERYTHRITOL (UNII: RA96B954X6)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)

Product Characteristics
Color	yellow (Clear to Yellow Clear)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69261-005-04	1 in 1 CARTON	01/25/2021
1		117.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69261-005-03	117.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/25/2021
3	NDC: 69261-005-05	1 in 1 PACKAGE	01/25/2021
3		117.5 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/25/2021

Labeler - Quip NYC Inc. (079453380)