Drugplain

Hismile 2.4 mg/g

Mango Sorbet Flavor Sodium Fluoride Anticavity Toothpaste · GEL · Hismile Pty Ltd

No Recall History
Plain English

Hismile is a gel containing mango sorbet flavor sodium fluoride anticavity toothpaste at 2.4 mg/g, taken dental. Manufactured by Hismile Pty Ltd.

Key Facts

Brand Name
Hismile
Generic Name
Mango Sorbet Flavor Sodium Fluoride Anticavity Toothpaste
NDC Code (Product)
83013-313
Manufacturer
Hismile Pty Ltd
Strength
2.4 mg/g
Dosage Form
GEL
Route
DENTAL
Marketing Status
Application #
M021
Marketing Start
01/14/2024

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 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor. instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing.) supervise children as neceaasry until capable of using without supervision. children under 2 years of age: Consult a dentist or doctor.

Warnings

Warnings When using this product do not swallow do not use in eye area Keep out of reach of children under 6 years of age If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Frequently Asked Questions

What is Hismile used for?

Hismile contains Mango Sorbet Flavor Sodium Fluoride Anticavity Toothpaste. It is a gel taken dental. Consult your doctor for specific uses.

Is Hismile a controlled substance?

Hismile is not classified as a controlled substance by the DEA.

What is the generic name for Hismile?

The generic name for Hismile is Mango Sorbet Flavor Sodium Fluoride Anticavity Toothpaste. There are no other listed brand versions of Mango Sorbet Flavor Sodium Fluoride Anticavity Toothpaste.

What is the NDC code for Hismile 2.4 mg/g?

The NDC (National Drug Code) for Hismile 2.4 mg/g is 83013-313, listed by Hismile Pty Ltd.

Product NDC

83013-313

Package NDC

83013-313-06

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)