TOENAIL FUNGUS TREATMENT LIQUID- tolnaftate, undecylenic acid liquid

TOENAIL FUNGUS TREATMENT Liquid by

Drug Labeling and Warnings

TOENAIL FUNGUS TREATMENT Liquid by is a Otc medication manufactured, distributed, or labeled by Lianjiang Shanlilai E-commerce Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

TOENAIL FUNGUS TREATMENT Liquid

ACTIVE INGREDIENT

TOLNAFTATE 1%
UNDECYLENIC ACID 25%

PURPOSE

Anti-fungal

INDICATIONS & USAGE

For the effective treatment of nail fungus,discoloration,thickening,splitting,crum
bling and brittleness.

WARNINGS

For externat use only.

DO NOT USE

chlldren under 2 years of age.
pregnant or if there is any allergic reaction to this produce.

WHEN USING

When using this product Avoid contact with eyes.

STOP USE

Stop use and ask a doctor if lrritation occurs or discomfort persists.

KEEP OUT OF REACH OF CHILDREN

oif product gets Into eyes,flush with water for 15 minutes.

if swallowred,get medical help or contact a Poison Control Center rightaway.

DOSAGE & ADMINISTRATION

For initlal use, soak the affected part and soften the nalt in warm water.Gently remove dirt from the naiis, being careful not to damage the nail bed.
Apply full layers of nait solution with brush onto affected areas on ,around.and under nails,.A light tingle or burn is normal for the frst 10 minutes untilthe product is absorbed into the skin.
Apply the product twice a day, in the morning and at night.
Visible resuits will be seen in as little as 7 days, carry out regular use toprevent fungal growth.

STORAGE AND HANDLING

Store betwseen 15° to 30 ° C (59° to 86 ° F)Avoid freezing and excessive heat above 40° C(104° F)

INACTIVE INGREDIENT

ALCOHOL
DIMETHICONE
CETOSTEARYL ALCOHOL
TEA TREE OIL
PROPYLENE GLYCOL
TOCOPHEROL
SAFFLOWER OIL
WATER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOENAIL FUNGUS TREATMENT LIQUID 
tolnaftate, undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85038-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 mL
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALCOHOL (UNII: 3K9958V90M)
TEA TREE OIL (UNII: VIF565UC2G)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SAFFLOWER OIL (UNII: 65UEH262IS)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85038-002-01	1 in 1 PACKAGE	12/11/2024
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 85038-002-02	2 in 1 PACKAGE	12/11/2024
2		30 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	12/11/2024

Labeler - Lianjiang Shanlilai E-commerce Co., Ltd. (638192827)

Establishment
Name	Address	ID/FEI	Business Operations
Lianjiang Shanlilai E-commerce Co., Ltd.		638192827	manufacture(85038-002)