SYLVIRENE FUNGAL NAIL RENEWAL- tolnaftate 1% fungal nail renewal liquid

SYLVIRENE FUNGAL NAIL RENEWAL by

Drug Labeling and Warnings

SYLVIRENE FUNGAL NAIL RENEWAL by is a Otc medication manufactured, distributed, or labeled by Jiangxi Hemei Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

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'sfoot (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

avoid contact with eyes.

Stop Use

irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

Ask Doctor

irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

Keep Oot Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

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 child ren in the use of this product. This product
is not effective for the treatment of ring worm of the scalp or nails. For athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventil ated 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.

Other information

Store at room
temperature 15-30℃ (59-86℉)

Inactive ingredients

water, euphorbia hirta whole, glycerin, hydracrylic acid, pseudolarix amabilis bark, resorcinol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SYLVIRENE FUNGAL NAIL RENEWAL 
tolnaftate 1% fungal nail renewal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
RESORCINOL (UNII: YUL4LO94HK)
WATER (UNII: 059QF0KO0R)
PSEUDOLARIX AMABILIS BARK (UNII: 49G13A93VE)
EUPHORBIA HIRTA WHOLE (UNII: L13YF113GN)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRACRYLIC ACID (UNII: C4ZF6XLD2X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-073-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/18/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	02/18/2025

Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(84010-073)