DERMFREE HELPS WITH NAGELPILZ by Jiangxi Hemei Pharmaceutical Co., Ltd 84010-097 complete

DERMFREE HELPS WITH NAGELPILZ by

Drug Labeling and Warnings

DERMFREE HELPS WITH NAGELPILZ by is a Otc medication manufactured, distributed, or labeled by Jiangxi Hemei Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DERMFREE HELPS WITH NAGELPILZ- tolnaftate 1% helps with nagelpilz liquid 
Jiangxi Hemei Pharmaceutical Co., Ltd

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84010-097 complete

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Use

Antifungal treatment for fingernails,toenails, and surrounding skin.Effective against fungal nails and athlete's foot caused by fungi.

Warnings

For external use only.

Do not use

if you experience any signs of sensitivity or irritation

When Using

Not for use in the eyes, mouthor vaginal area.

Stop Use

lf the area of application showsincreased irritationlf there is Consult a doctor ifsymptoms worsen.If pregnant or breaslleeding

Ask Doctor

lf the area of application showsincreased irritationlf there is Consult a doctor ifsymptoms worsen.If pregnant or breaslleeding

Keep Oot Of Reach Of Children

lf accidental ingestion occurs,seek medical assistance or contact a Poison Control Centerimmediately.

Directions

For athlete's foot and ring worm：use daily for 4 weeks.Clean the affected area and dry thoroughly.Keep away from fire and flames.For external use on nails and the immediately adjacent skin only.Use once daily, preferably before bedtime.
Unscrew the bottle cap and use the brush to apply the medicine directlyto the nail.The medication will then penetrate deeply into the nail.If the nail area is infected, spray the medication onto the affected area.SHAKE WELL BEFORE USE.Store at 5'c to 30°0(41'F to 86°F) in a cool dry place. Keep tighosedand away from sunlight.

Inactive ingredients

water, euphorbia hirta whole, glycerin, hydracrylic acid, pseudolarixamabilis bark, resorcinol.

PRINCIPAL DISPLAY PANEL

DERMFREE HELPS WITH NAGELPILZ 
tolnaftate 1% helps with nagelpilz liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-097
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
EUPHORBIA HIRTA WHOLE (UNII: L13YF113GN)
PSEUDOLARIX AMABILIS BARK (UNII: 49G13A93VE)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYDRACRYLIC ACID (UNII: C4ZF6XLD2X)
RESORCINOL (UNII: YUL4LO94HK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-097-01	4 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2025
2	NDC: 84010-097-02	3 in 1 BOX	04/15/2025
2		4 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	04/15/2025	02/08/2026

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

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(84010-097)

Revised: 2/2026

Document Id: 4a47fee3-7a71-239d-e063-6294a90a0c3a

34390-5

Set id: 32c94b5d-b77c-ad01-e063-6394a90a1cba

Version: 3

Effective Time: 20260207