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 Guangzhou Ruijiu Electronic Technology 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, thickeningsplitting,crumbling and brittleness.

WARNINGS

For external use only.

DO NOT USE

Children 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

If product gets into eyes,flush with water for 15 minutes.

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

DOSAGE & ADMINISTRATION

For initial use, soak the affected nail in warm water to soften it.Gently fle thenail to make it thinner and remove dirt, being cautiousnot to harm the nail bed.
Apply full layers of nail solution with brush onto affected areas onaround ,and under nails. A light tingle or burn is normal for the frst10 minutes until the product is absorbed into the skin.
Apply the product twice a day, in the morning and at night.
Visible results will be seen in as little as 6 weeks, continue regularusage to prevent fungus regrowth.

STORAGE AND HANDLING

heat above 40'C(104°)
Store between 15° to 30 °C (59°to 86 ℉ )Avoid freezing and excessive

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: 83767-701
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
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83767-701-01	1 in 1 PACKAGE	09/03/2024
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 83767-701-02	2 in 1 PACKAGE	09/03/2024
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	09/03/2024

Labeler - Guangzhou Ruijiu Electronic Technology Co., Ltd. (631973699)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Ruijiu Electronic Technology Co., Ltd.		631973699	manufacture(83767-701)