SPL v1
SPL
SPL Set ID 49457b38-e25e-7671-e063-6294a90a208a
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 (18.84 mg) Borneol (1 mg) Cinnamon Bark Oil (0.004 mg)
Inactive Ingredients
Water Urea Chlorhexidine Gluconate Glycerin Zinc Oxide Allantoin 1,2-hexanediol

Identifiers & Packaging

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

Description

CHLORHEXIDINE GLUCONATE、BORNEOL、TEA TREE OIL、CINNAMON BARK OIL


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

Penetrates deeply into the base of nails to fight nail fungus; repairs damaged nail beds and promotes nail growth; penetrates deeply to restore nail luster.

Dosage and Administration

Penetrates deeply into the base of nails to fight nail fungus; repairs damaged nail beds and promotes nail growth; penetrates deeply to restore nail luster.

Description

CHLORHEXIDINE GLUCONATE、BORNEOL、TEA TREE OIL、CINNAMON BARK OIL

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

Penetrates deeply into the base of nails to fight nail fungus; repairs damaged nail beds and promotes nail growth; penetrates deeply to restore nail luster.

Section 50570-1

Discontinue use if signs of irritation or rash occur.

Section 51727-6

WATER、UREA、1,2-HEXANEDIOL、GLYCERIN、ALLANTOIN、ZINC OXIDE

Section 51945-4

Section 55105-1

1. Powerful antibacterial: effectively sterilizes, inhibits fungal growth, and quickly relieves onychomycosis.

2. Deep repair: Go deep into the root of the nail to promote healthy nail growth and repair damaged tissue.

3. Mild ingredients: It uses mild ingredients, does not contain harmful chemicals, is safe, mild and non-irritating.

4. Easy to use: easy to apply, quickly absorbed, and leaves no greasy feeling.

5. Provide long-term protection to prevent the recurrence of onychomycosis and keep nails healthy.

6. Mild formula, suitable for long-term use without side effects.

7. Provides anti-inflammatory effects, reduces redness, swelling and pain, and relieves discomfort.

8. Suitable for all nail types, comprehensive care for nail health.

9. Provides moisturizing effect and prevents nails from dryness and brittleness.

10. Can stimulate blood circulation and promote nail growth.

11. Contains nourishing ingredients to enhance nail toughness and prevent breakage.

12. No irritating smell, more comfortable to use.

13. Quick results, significantly improving onychomycosis in a short period of time.

14. Provide a protective layer to resist external pollution and bacterial invasion.

15. Suitable for use by the whole family, including the elderly and adults.

Section 55106-9

CHLORHEXIDINE GLUCONATE、BORNEOL、TEA TREE OIL、CINNAMON BARK OIL


Structured Label Content

Indications and Usage (34067-9)

Penetrates deeply into the base of nails to fight nail fungus; repairs damaged nail beds and promotes nail growth; penetrates deeply to restore nail luster.

Dosage and Administration (34068-7)

Penetrates deeply into the base of nails to fight nail fungus; repairs damaged nail beds and promotes nail growth; penetrates deeply to restore nail luster.

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)

Penetrates deeply into the base of nails to fight nail fungus; repairs damaged nail beds and promotes nail growth; penetrates deeply to restore nail luster.

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、ZINC OXIDE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

1. Powerful antibacterial: effectively sterilizes, inhibits fungal growth, and quickly relieves onychomycosis.

2. Deep repair: Go deep into the root of the nail to promote healthy nail growth and repair damaged tissue.

3. Mild ingredients: It uses mild ingredients, does not contain harmful chemicals, is safe, mild and non-irritating.

4. Easy to use: easy to apply, quickly absorbed, and leaves no greasy feeling.

5. Provide long-term protection to prevent the recurrence of onychomycosis and keep nails healthy.

6. Mild formula, suitable for long-term use without side effects.

7. Provides anti-inflammatory effects, reduces redness, swelling and pain, and relieves discomfort.

8. Suitable for all nail types, comprehensive care for nail health.

9. Provides moisturizing effect and prevents nails from dryness and brittleness.

10. Can stimulate blood circulation and promote nail growth.

11. Contains nourishing ingredients to enhance nail toughness and prevent breakage.

12. No irritating smell, more comfortable to use.

13. Quick results, significantly improving onychomycosis in a short period of time.

14. Provide a protective layer to resist external pollution and bacterial invasion.

15. Suitable for use by the whole family, including the elderly and adults.

Section 55106-9 (55106-9)

CHLORHEXIDINE GLUCONATE、BORNEOL、TEA TREE OIL、CINNAMON BARK OIL


Advanced Ingredient Data


Raw Label Data

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