ARIELLA NAIL REPAIR PEN- poliglusam, salicylic acid liquid

Ariella Nail Repair Pen by

Drug Labeling and Warnings

Ariella Nail Repair Pen by is a Otc medication manufactured, distributed, or labeled by YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient                               Purpose

Chitosan   2%                                  Anti-fungal

Salicylic Acid   3%                            Anti-fungal

PURPOSE

Uses

Treatment of fingernail and toenail fungus

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 and ask a doctor if - irritation occurs - there is no improvement within 4 weeks

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Directions

• Soak your feet in hot water for 5 minutes, then dry your toes.
• Use a nail cutter and file (not included) to trim nails that need repair so that the liquid can soak in better.
• Gently turn the end of the pen to dispense treatment liquid onto the brush applicator.
• Apply the liquid over the areas that need to be repaired, and make sure to cover all affected parts.
• Use daily for 2-4 weeks, according to the condition of the area that needs repair.
• Recommended use: 2-3 times a day.

Other information

store at 15-28°C (59.0-82.4°F)

Inactive ingredients

Aqua, Sorbitol, Alcohol, Propylene Glycol, Angelica Dahurica Extract,Chlorhexidine Diacetate, Laurocapram, Caramel

Questions or comments?

Contact us at www.tryariella.com or email cs@tryariella.com

Product label

INGREDIENTS AND APPEARANCE

ARIELLA NAIL REPAIR PEN 
poliglusam, salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83364-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLIGLUSAM (UNII: 82LKS4QV2Y) (POLIGLUSAM - UNII:82LKS4QV2Y)	POLIGLUSAM	2 g  in 100 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ANGELICA DAHURICA WHOLE (UNII: 667W6C5J4P)
CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y)
LAUROCAPRAM (UNII: 1F3X9DRV9X)
CARAMEL (UNII: T9D99G2B1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83364-001-01	2 in 1 BOX	05/12/2023
1		3 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 83364-001-02	4 in 1 BOX	05/12/2023
2		3 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/12/2023

Labeler - YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD (725220463)

Establishment
Name	Address	ID/FEI	Business Operations
YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD		725220463	manufacture(83364-001)