Drugplain

SmileCare Mouth Ulcer Gel .1 g/100g

Menthol · GEL · Yantai Aien Biotechnology Co., Ltd.

No Recall History
Plain English

Smilecare Mouth Ulcer Gel is an over-the-counter menthol gel applied directly to the mouth to help relieve pain and discomfort from mouth ulcers. The menthol provides a cooling sensation that can soothe irritated areas in the mouth.

Key Facts

Brand Name
SmileCare Mouth Ulcer Gel
Generic Name
Menthol
NDC Code (Product)
87512-004
Manufacturer
Yantai Aien Biotechnology Co., Ltd.
Strength
.1 g/100g
Dosage Form
GEL
Route
ORAL
Marketing Status
Application #
M022
Marketing Start
03/20/2026

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Directions Adults and children 2 years of ageand older: Apply a small amountof gel to the affected area of themouth. Gargle, swish around, orallow to remain in place at least 1minute and then spit out. Use upto 4 times daily or as directed by adentist or doctor.Children under 12 years of ageshould be supervised in the use of this product.Children under 2 years of age:Consult a dentist or doctor.

Dosage & Administration

Apply a small amount of gel to the affected area of the mouth. Gargle, swish around, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.

Warnings

Warnings Do not use In children under 2 years of age unless directed by a doctor Sore throat warnings 1If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.

Frequently Asked Questions

What is SmileCare Mouth Ulcer Gel used for?

Smilecare Mouth Ulcer Gel is an over-the-counter menthol gel applied directly to the mouth to help relieve pain and discomfort from mouth ulcers. The menthol provides a cooling sensation that can soothe irritated areas in the mouth.

Is SmileCare Mouth Ulcer Gel a controlled substance?

SmileCare Mouth Ulcer Gel is not classified as a controlled substance by the DEA.

What is the generic name for SmileCare Mouth Ulcer Gel?

The generic name for SmileCare Mouth Ulcer Gel is Menthol. There are 12 other brand versions of Menthol.

What is the NDC code for SmileCare Mouth Ulcer Gel .1 g/100g?

The NDC (National Drug Code) for SmileCare Mouth Ulcer Gel .1 g/100g is 87512-004, listed by Yantai Aien Biotechnology Co., Ltd..