Label: ARIELLA NAIL REPAIR PEN- poliglusam, salicylic acid liquid
- NDC Code(s): 83364-001-01, 83364-001-02
- Packager: YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated May 11, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient Purpose
- PURPOSE
- Uses
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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
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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
- Inactive ingredients
- Questions or comments?
- Product label
-
INGREDIENTS AND APPEARANCE
ARIELLA NAIL REPAIR PEN
poliglusam, salicylic acid liquidProduct 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)
