Otc - Active Ingredient
Active ingredient
Purpose
Menthol(0.1%)...... Oral pain reliever
Smilecare Mouth Ulcer Gel
FDA Label NDC 87512-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yantai Aien Biotechnology Co., Ltd. for the product Smilecare Mouth Ulcer Gel (NDC 87512-004). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, dosage & administration, warnings, indications & usage, inactive ingredient, 87512-004-01 smilecare mouth ulcer gel 10g, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
Temporarily relieves occasional
minor irritation and pain
associated with sore mouth and
sore throat.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
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.
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.
Inactive Ingredient
Inactive ingredients
Polihexanide, Riboflavin, Ferrous
Sulfate, Sorbitol, Sodium Alginate,
Glycerin, Niacinamide, Carbomer
Homopolymer, Trolamine, Water
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