QQE FUNGAL NAIL TREATMENT- tolnaftate 1% cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Tolnaftate 1%

INACTIVE INGREDIENT

Lactic Acid, Acetic Acid, Salicylic Acid, Aloe Vera Extract, Helianthus Annuus (Sunflower) Seed Oil, Prunus Armeniaca (Apricot) Kernel Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eugenia Caryophyllus (Clove) Bud Oil, Lavandula Angustifolia (Lavender) Oil, Hakka Yu, Tocopherol, Origanum Vulgare Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Eucalyptol, Tocopheryl Acetate, Squalene, Propolis Extract, Citrus Bergamia (Bergamot) Fruit Oil.

PURPOSE

Antifungal

INDICATIONS & USAGE

For the treatment of nail fungus and associated symptoms, including discoloration, thickening, splitting, crumbling, and brittleness. Cures most Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis) Relieves itching, scaling, cracking, burning, redness, soreness, irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.

WARNINGS

For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product, avoid contact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Store at room temperature 15°-25° (59°-77°F). Avoid direct sunlight.

WHEN USING

Before use, rotate the product's safety valve to the right to open it. Apply 2-3 drops of the solution directly onto the affected nail, ensuring it covers the entire nail surface and the surrounding edges; allow the solution to be fully absorbed and dry completely. Apply twice daily (once in the morning and once at night), or as directed by a physician.

DO NOT USE

Do not use on children under 2 years of age unless directed by a doctor

STOP USE

Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks.

DOSAGE & ADMINISTRATION

Use 2-3 times per week or as needed.,(5ml-10ml)each time.15 weeks supply

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QQE FUNGAL NAIL TREATMENT 
tolnaftate 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87204-175
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
LACTIC ACID (UNII: 33X04XA5AT)
(1-CYANOCYCLOHEXYL)ACETIC ACID (UNII: E1393FZ76L)
SALICYLIC ACID (UNII: O414PZ4LPZ)
EUCALYPTOL (UNII: RV6J6604TK)
SQUALENE (UNII: 7QWM220FJH)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87204-175-01	15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/05/2026	05/31/2027

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/05/2026	05/31/2027

Labeler - Guangzhou Huixue Biotechnology Co., Ltd. (418186127)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Huixue Biotechnology Co., Ltd.		418186127	label(87204-175)