SERYNTH Multi-Purpose Nail Solution
84010-118
35c95039-95e4-272b-e063-6294a90aeadc
HUMAN OTC DRUG LABEL
May 23, 2025
Jiangxi Hemei Pharmaceutical Co., Ltd
DUNS: 724892056
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tolnaftate 1% Multi-Purpose Nail Solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (7)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Use
Cures most Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis).
Relieves itching, scaling, cracking, burning,
redness, sorenes, and irritation and discomfort. Helps prevent most athlete's
foot (dermatophytosis) with daily use.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Tolnaftate 1%
OTC - PURPOSE SECTION
Purpose
Antifungal
WARNINGS SECTION
Warnings
For external use only.
OTC - DO NOT USE SECTION
Do not use
on children under 2 years of age unless directed by a doctor.
OTC - WHEN USING SECTION
When Using
avoid contact with eyes.
OTC - STOP USE SECTION
Stop Use
irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).
OTC - ASK DOCTOR SECTION
Ask Doctor
irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
For athlete's foot and ring
worm: use daily for 4 weeks. Clean the affected area and dry thoroughly. Apply
a thin layer of the product over affected
area twice daily (morning and night) or as directed by a doctor. Supervise
children in the use of this product. This product
is not effective for the treatment of ringworm of the scalp or nails. For
athlete's foot: pay special attention to spaces
between the toes, wear well-fitting, ventilated shoes, and change shoes and
socks at least once daily. To prevent
athlete's foot, apply once or twice daily (morning and/or night). Apply to
skin around the nail and cuticle.
STORAGE AND HANDLING SECTION
Other information
Store at room
temperature 15-30℃ (59-86℉)
INACTIVE INGREDIENT SECTION
Inactive ingredients
water, euphorbia hirta whole, glycerin, hydracrylic acid, pseudolarix amabilis bark, resorcinol.