Drugplain

Hello Unicorn Splash unicorn splash anticavity fluoride rinse .02 g/100mL

sodium fluoride · MOUTHWASH · Colgate-Palmolive Company

No Recall HistoryCurrently in Shortage
Plain English

Sodium fluoride mouthwash is an over-the-counter dental rinse used to help prevent tooth decay and cavities. You use it by rinsing your mouth as directed on the package label.

Key Facts

Brand Name
Hello Unicorn Splash unicorn splash anticavity fluoride rinse
Generic Name
sodium fluoride
NDC Code (Product)
35000-687
Manufacturer
Colgate-Palmolive Company
Strength
.02 g/100mL
Dosage Form
MOUTHWASH
Route
DENTAL
Marketing Status
Application #
M021
Marketing Start
07/01/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pyrexia170 reports
fatigue159 reports
nausea158 reports
vomiting156 reports
pain154 reports
weight increased154 reports
nasopharyngitis152 reports
type 2 diabetes mellitus145 reports
peripheral swelling144 reports
urticaria143 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use aids in the prevention of dental cavities.

Dosage & Administration

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 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

Warnings

Warnings 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.

Frequently Asked Questions

What is Hello Unicorn Splash unicorn splash anticavity fluoride rinse used for?

Sodium fluoride mouthwash is an over-the-counter dental rinse used to help prevent tooth decay and cavities. You use it by rinsing your mouth as directed on the package label.

Is Hello Unicorn Splash unicorn splash anticavity fluoride rinse a controlled substance?

Hello Unicorn Splash unicorn splash anticavity fluoride rinse is not classified as a controlled substance by the DEA.

What is the generic name for Hello Unicorn Splash unicorn splash anticavity fluoride rinse?

The generic name for Hello Unicorn Splash unicorn splash anticavity fluoride rinse is sodium fluoride. There are 12 other brand versions of sodium fluoride.

What is the NDC code for Hello Unicorn Splash unicorn splash anticavity fluoride rinse .02 g/100mL?

The NDC (National Drug Code) for Hello Unicorn Splash unicorn splash anticavity fluoride rinse .02 g/100mL is 35000-687, listed by Colgate-Palmolive Company.