Active Ingredient
Sodium fluoride 0.05% (0.02% w/v fluoride ion)
Hello Unicorn Splash Mouthwash
FDA Label NDC 44038-0687
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Accupac Llc for the product Hello Unicorn Splash (NDC 44038-0687). 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 active ingredient, purpose, use, keep out of reach of children., directions, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Use
aids in the prevention of dental cavities.
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 once a day after brushing your teeth with a toothpaste.
Vigorously swith 10 mL (2 teaspoons) 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).
Surpervise children as necessary until capable of using without supervision.
Children under 6 years of age: consult dentist or doctor.
Other Information
Store at room temperature
Do not use if printed band around cap is broken or missing.
Inactive Ingredients
purified water, vegetable glycerin, xylitol, sodium phosphate monobasic, flavor, poloxamer 407, potassium citrate, phosphoric acid.
Questions?
1-855-444-3556
Dist. by Hello Products LLC
Montclair, NJ 07042
Principal Display Panel - 473 Ml Bottle Label
naturally
friendly
hello
unicorn splash
anticavity fluoride rinse
bubble gum
natural flavor
prevents cavities
no alcohol
strengthens teeth
tastes magical
works brilliantly
no artificial sweeteners. no dyes.
no SLS/sulfates. no brainer.
16 FL OZ (1 PT) 473 mL
44917
* Please review the disclaimer below.
