SPL v1
SPL
SPL Set ID 49451717-e41c-8ae0-e063-6294a90a91ad
Route
TOPICAL
Published
Effective Date 2026-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tea Tree Oil (0.012 mg)
Inactive Ingredients
Chlorhexidine Gluconate Urea Undecylenic Acid 1,2-hexanediol Borneol Glycerin Allantoin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-26
Description

1. Nail Repair: Helps improve damaged fingernails and toenails. 2. Crack Reduction: Effectively reduces cracks and brittle nails. 3. Nail Strengthening: Improves nail strength and promotes long-term health. 4. Gloss Enhancement: Enhances nail luster and improves appearance. 5. Pen-shaped design allows for convenient and precise application anytime, anywhere. 6. Suitable for daily nail care, maintaining nail integrity. 7. Supports nail regeneration, promoting long-term healthy nail growth. 8. Gentle formula, gentle on nails and surrounding skin. 9. Absorbs quickly, leaving no sticky residue. 10. Suitable for both fingernails and toenails, providing comprehensive care. 11. Portable, perfect for on-the-go nail care. 12. Maintains nail integrity and reduces daily breakage. 13. Enhances the natural health of nails while also brightening them. 14. Easy to use, suitable for all ages. 15. With continued use, your nails will show visible health changes.

Medication Information

Warnings and Precautions

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Indications and Usage

Helps improve damaged fingernails and toenails; reduces nail cracking and brittleness; supports long-term nail regeneration and growth; improves nail health and luster; and improves nail appearance

Dosage and Administration

Helps improve damaged fingernails and toenails; reduces nail cracking and brittleness; supports long-term nail regeneration and growth; improves nail health and luster; and improves nail appearance

Description

1. Nail Repair: Helps improve damaged fingernails and toenails. 2. Crack Reduction: Effectively reduces cracks and brittle nails. 3. Nail Strengthening: Improves nail strength and promotes long-term health. 4. Gloss Enhancement: Enhances nail luster and improves appearance. 5. Pen-shaped design allows for convenient and precise application anytime, anywhere. 6. Suitable for daily nail care, maintaining nail integrity. 7. Supports nail regeneration, promoting long-term healthy nail growth. 8. Gentle formula, gentle on nails and surrounding skin. 9. Absorbs quickly, leaving no sticky residue. 10. Suitable for both fingernails and toenails, providing comprehensive care. 11. Portable, perfect for on-the-go nail care. 12. Maintains nail integrity and reduces daily breakage. 13. Enhances the natural health of nails while also brightening them. 14. Easy to use, suitable for all ages. 15. With continued use, your nails will show visible health changes.

Section 44425-7

Store in a cool and dry place.

Section 50565-1

Please keep out of reach of children. Do not swallow.

Section 50566-9

Discontinue use if signs of irritation or rash occur.

Section 50567-7

Helps improve damaged fingernails and toenails; reduces nail cracking and brittleness; supports long-term nail regeneration and growth; improves nail health and luster; and improves nail appearance

Section 50570-1

Discontinue use if signs of irritation or rash occur.

Section 51727-6

WATER、UREA、1,2-HEXANEDIOL、GLYCERIN、ALLANTOIN、UNDECYLENIC ACID

Section 51945-4

Section 55105-1

1. Nail Repair: Helps improve damaged fingernails and toenails.

2. Crack Reduction: Effectively reduces cracks and brittle nails.

3. Nail Strengthening: Improves nail strength and promotes long-term health.

4. Gloss Enhancement: Enhances nail luster and improves appearance.

5. Pen-shaped design allows for convenient and precise application anytime, anywhere.

6. Suitable for daily nail care, maintaining nail integrity.

7. Supports nail regeneration, promoting long-term healthy nail growth.

8. Gentle formula, gentle on nails and surrounding skin.

9. Absorbs quickly, leaving no sticky residue.

10. Suitable for both fingernails and toenails, providing comprehensive care.

11. Portable, perfect for on-the-go nail care.

12. Maintains nail integrity and reduces daily breakage.

13. Enhances the natural health of nails while also brightening them.

14. Easy to use, suitable for all ages.

15. With continued use, your nails will show visible health changes.

Section 55106-9

CHLORHEXIDINE GLUCONATE、BORNEOL、TEA TREE OIL

Structured Label Content

Indications and Usage (34067-9)

Helps improve damaged fingernails and toenails; reduces nail cracking and brittleness; supports long-term nail regeneration and growth; improves nail health and luster; and improves nail appearance

Dosage and Administration (34068-7)

Helps improve damaged fingernails and toenails; reduces nail cracking and brittleness; supports long-term nail regeneration and growth; improves nail health and luster; and improves nail appearance

Warnings and Precautions (34071-1)

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Section 44425-7 (44425-7)

Store in a cool and dry place.

Section 50565-1 (50565-1)

Please keep out of reach of children. Do not swallow.

Section 50566-9 (50566-9)

Discontinue use if signs of irritation or rash occur.

Section 50567-7 (50567-7)

Helps improve damaged fingernails and toenails; reduces nail cracking and brittleness; supports long-term nail regeneration and growth; improves nail health and luster; and improves nail appearance

Section 50570-1 (50570-1)

Discontinue use if signs of irritation or rash occur.

Section 51727-6 (51727-6)

WATER、UREA、1,2-HEXANEDIOL、GLYCERIN、ALLANTOIN、UNDECYLENIC ACID

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

1. Nail Repair: Helps improve damaged fingernails and toenails.

2. Crack Reduction: Effectively reduces cracks and brittle nails.

3. Nail Strengthening: Improves nail strength and promotes long-term health.

4. Gloss Enhancement: Enhances nail luster and improves appearance.

5. Pen-shaped design allows for convenient and precise application anytime, anywhere.

6. Suitable for daily nail care, maintaining nail integrity.

7. Supports nail regeneration, promoting long-term healthy nail growth.

8. Gentle formula, gentle on nails and surrounding skin.

9. Absorbs quickly, leaving no sticky residue.

10. Suitable for both fingernails and toenails, providing comprehensive care.

11. Portable, perfect for on-the-go nail care.

12. Maintains nail integrity and reduces daily breakage.

13. Enhances the natural health of nails while also brightening them.

14. Easy to use, suitable for all ages.

15. With continued use, your nails will show visible health changes.

Section 55106-9 (55106-9)

CHLORHEXIDINE GLUCONATE、BORNEOL、TEA TREE OIL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:21.988208 · Updated: 2026-03-14T23:12:35.594126