FOOT CURE NAIL REPAIR PEN- antifungal nail repair pen solution

Foot Cure Nail Repair Pen by

Drug Labeling and Warnings

Foot Cure Nail Repair Pen by is a Otc medication manufactured, distributed, or labeled by SANSAR, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Undecylenic Acid 25%

Purpose

Antifungal

Uses 

For the Effective treatment of nail fungus, discoloration, thickening, splitting, crumbling and britteleness 

Warnings

For external use only.

Do not use

•  on children under 2 years of age unless directed by a doctor.

When using this product

• avoid contact with eyes.

Stop use and ask a doctor if

•  irritation occurs or there is no improvement within 4 weeks.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

1. Apply the product twice a day, in the morning and at night.

2. For initial use, soak the affected nail in warm water to soften it. Gently file the nail to make it thinner and remove dirt, being cautios not to harm the nail bed. For best results file nails every 2-3 days.

3. Use the Nail Repair pen brush to apply the solution on the affected areas.

4. Visible results will be seen in as little as 7 days, continue regular usage to prevent fungus regrowth.

Inactive Ingredients

Aloe Vera Extract, Canola Oil, Clove bud oil, Lavender oil, Jojoba Oil, Manuka Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Sweet Almond oil, Tea tree oil, Tocopheryl Acetate (Vitamin E)

NDC 83691-011-01

NDC:

83691-011-02

INGREDIENTS AND APPEARANCE

FOOT CURE NAIL REPAIR PEN 
antifungal nail repair pen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83691-011
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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CANOLA OIL (UNII: 331KBJ17RK)
CLOVE OIL (UNII: 578389D6D0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
JOJOBA OIL (UNII: 724GKU717M)
MANUKA OIL (UNII: M6QU9ZUH2X)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
PEPPERMINT OIL (UNII: AV092KU4JH)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
ALMOND OIL (UNII: 66YXD4DKO9)
TEA TREE OIL (UNII: VIF565UC2G)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83691-011-01	4 in 1 CARTON	07/26/2024
1		3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 83691-011-02	2 in 1 CARTON	07/26/2024
2		3 mL in 1 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	07/26/2024

Labeler - SANSAR, LLC (127927811)