FOOT CURE 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, 093638579. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Undecylenic Acid 25%...........................Antifungal

INTENDED USE OF THE DEVICE

For the effective treatment of nail fungus, discolartion, thickening, splitting, crumbling and brittleness.

WARNINGS

For external use only.

WARNINGS AND PRECAUTIONS

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

INACTIVE INGREDIENT

Alo 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)

DOSAGE & ADMINISTRATION

3ml X 4 Pen

INDICATIONS & USAGE

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

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

For the effective treatment of nail fungus, discolartion, thickening, splitting, crumbling and brittleness.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOOT CURE NAIL REPAIR PEN 
foot cure nail repair pen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83691-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALMOND OIL (UNII: 66YXD4DKO9)
CLOVE OIL (UNII: 578389D6D0)
PEPPERMINT OIL (UNII: AV092KU4JH)
JOJOBA OIL (UNII: 724GKU717M)
MANUKA OIL (UNII: M6QU9ZUH2X)
CANOLA OIL (UNII: 331KBJ17RK)
TEA TREE OIL (UNII: VIF565UC2G)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83691-002-01	3 g in 1 BOX; Type 0: Not a Combination Product	07/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	07/25/2024

Labeler - Sansar LLC (127927811)

Establishment
Name	Address	ID/FEI	Business Operations
093638579		093638579	manufacture(83691-002)