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Distributed by: quip NYC Inc., 45 Main Street, Brooklyn, NY 11201, USA
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Quip Anticavity Fluoride Mouthwash
FDA Label NDC 69261-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quip Nyc Inc. for the product Quip Anticavity Fluoride (NDC 69261-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (diluted solution)
0.05% Sodium fluoride (0.02% w/v fluoride ion)
Otc - Purpose
Purpose
Anticavity
Indications & Usage
Use
Aids in prevention of dental cavities
Warnings
Warnings
Otc - 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
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
201215_hudson_package (201215 Hudson Package)
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