SMILECARE MOUTH ULCER GEL- menthol gel

SmileCare Mouth Ulcer Gel by

Drug Labeling and Warnings

SmileCare Mouth Ulcer Gel by is a Otc medication manufactured, distributed, or labeled by Yantai Aien Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Purpose
Menthol(0.1%)...... Oral pain reliever

PURPOSE

Uses
Temporarily relieves occasional
minor irritation and pain
associated with sore mouth and
sore throat.

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

87512-004-01 SmileCare Mouth Ulcer Gel 10g

87512-004-02 SmileCare Mouth Ulcer Gel 15g

87512-004-03 SmileCare Mouth Ulcer Gel 20g

INGREDIENTS AND APPEARANCE

SMILECARE MOUTH ULCER GEL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87512-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM ALGINATE (UNII: C269C4G2ZQ)
GLYCERIN (UNII: PDC6A3C0OX)
RIBOFLAVIN (UNII: TLM2976OFR)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
NIACINAMIDE (UNII: 25X51I8RD4)
POLIHEXANIDE (UNII: 322U039GMF)
SORBITOL (UNII: 506T60A25R)
FERROUS SULFATE (UNII: 39R4TAN1VT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87512-004-01	10 g in 1 TUBE; Type 0: Not a Combination Product	03/20/2026
2	NDC: 87512-004-02	15 g in 1 TUBE; Type 0: Not a Combination Product	03/20/2026
3	NDC: 87512-004-03	20 g in 1 TUBE; Type 0: Not a Combination Product	03/20/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	03/20/2026

Labeler - Yantai Aien Biotechnology Co., Ltd. (977916686)