ARIELLA NAIL REPAIR PEN- poliglusam, salicylic acid liquid 
YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredient                               Purpose

Chitosan   2%                                  Anti-fungal

Salicylic Acid   3%                            Anti-fungal

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.

Directions

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

image description

ARIELLA NAIL REPAIR PEN 
poliglusam, salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83364-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLIGLUSAM (UNII: 82LKS4QV2Y) (POLIGLUSAM - UNII:82LKS4QV2Y) POLIGLUSAM2 g  in 100 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83364-001-012 in 1 BOX05/12/2023
13 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:83364-001-024 in 1 BOX05/12/2023
23 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/12/2023
Labeler - YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD (725220463)
Establishment
NameAddressID/FEIBusiness Operations
YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD725220463manufacture(83364-001)

Revised: 5/2023
Document Id: fb6cf72b-f2f2-3e8b-e053-6294a90a2231
Set id: 069c1bf6-9df0-4e86-9928-f81cb59244c3
Version: 1
Effective Time: 20230511
 
YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD