RDVHDLW EXTRA STRENGTH NAIL REPAIR PEN- tolnaftate, undecylenic acid liquid

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Tolnaftate1%

Undecylenic Acid 25%

PURPOSE

Anti-fungal and Nail Renewal

INDICATIONS & USAGE

STRENGTH PENS: Targets foot fungus & discoloration, Fast-drying & easy application, For daily antifungal care.
REPAIR PENS: Hydrates dry, cracked skin, Soothes & restores rough feet,Improves overall foot appearance.

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

Avoid contact with eyes. If in eyes, rinse thoroughly with water.

STOP USE

Irritation occurs or discomfort persists.

KEEP OUT OF REACH OF CHILDREN

If accidental ingestion occurs, seek medical attention immediately and contact a Poison Control Center.

DOSAGE & ADMINISTRATION

1.Wash and dry your nails thoroughly before applying the product. Remove the cap thatcovers the brush.

2.Press the button at the end of the pen to dispense the liquid onto the brush.

3.Apply the liquid three times to the areas requiring treatment, ensuring complete coverageof all affected parts.
4.Use 2-3 times daily for 2-4 weeks, depending on the condition being treated.

INACTIVE INGREDIENT

ALCOHOL
POLYETHYLENE GLYCOL
PROPYLENE GLYCOL
DIMETHICONE
C12-15 ALKYL LACTATE
ETHYLHEXYLGLYCERIN
GLYCERIN
LAUROCAPRAM
SOPHORA FLAVESCENS ROOT
TOCOPHEROL
PHENOXYETHANOL
WATER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RDVHDLW EXTRA STRENGTH NAIL REPAIR PEN 
tolnaftate, undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83766-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	0.25 g  in 1 mL
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	0.01 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
TOCOPHEROL (UNII: R0ZB2556P8)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
LAUROCAPRAM (UNII: 1F3X9DRV9X)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83766-001-01	5 in 1 PACKAGE	04/14/2026
1		5 mL in 1 BOTTLE, WITH APPLICATOR; 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	04/14/2026

Labeler - Shenzhen Joyuflsh Technology Co.,Ltd. (603012375)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Joyuflsh Technology Co.,Ltd.		603012375	manufacture(83766-001)