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SPL v1

SPL

SPL Set ID 48793a50-89a7-dba9-e063-6394a90a7056

Route

TOPICAL

Published

Effective Date 2026-01-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Aloe Barbadensis Leaf (0.06 mg) Sophora Flavescens Root (0.012 mg)

Inactive Ingredients

Allantoin Glycerin Aqua

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2026-01-16

Description

SOPHORA ANGUSTIFOLIA ROOT EXTRACT、ALOE BARBADENSIS EXTRACT

Medication Information

Warnings and Precautions

Keep out of reach of children.Avoid contact with eyes.Discontinue use if signs of irritation or rash occur.Store in a cool and dry place.

Indications and Usage

1. Wash and dry affected nails before going to bed

2. Open the package, take out the patch and tear off the back film

3. Place the patch on the nail and remove it after about 6-8 hours

Dosage and Administration

1. Wash and dry affected nails before going to bed

2. Open the package, take out the patch and tear off the back film

3. Place the patch on the nail and remove it after about 6-8 hours

Description

SOPHORA ANGUSTIFOLIA ROOT EXTRACT、ALOE BARBADENSIS EXTRACT

Section 44425-7

Store in a cool and dry place.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Discontinue use if signs of irritation or rash occur.

Section 50567-7

1. Wash and dry affected nails before going to bed

2. Open the package, take out the patch and tear off the back film

3. Place the patch on the nail and remove it after about 6-8 hours

Section 50570-1

Discontinue use if signs of irritation or rash occur.

Section 51727-6

AQUA、GLYCERIN、ALLANTOIN

Section 51945-4

Section 55105-1

1. A variety of moisturizing ingredients are absorbed into nails and skin through the patch, deeply nourishing, hydrating brittle nails, and reducing the appearance of thick and discolored nails.

2. Replenish nails with necessary moisture and nutrients, quickly reduce brittle manicure overnight, and restore manicure to show its natural, healthy appearance.

3. Hygienic material support, soft and strong, can provide gentle repair to nails.

4. The packaging is compact and easy to use. The patch design is suitable for carrying when going out and can be used anytime and anywhere.

Section 55106-9

SOPHORA ANGUSTIFOLIA ROOT EXTRACT、ALOE BARBADENSIS EXTRACT

Structured Label Content

Indications and Usage (34067-9)

1. Wash and dry affected nails before going to bed

2. Open the package, take out the patch and tear off the back film

3. Place the patch on the nail and remove it after about 6-8 hours

Dosage and Administration (34068-7)

1. Wash and dry affected nails before going to bed

2. Open the package, take out the patch and tear off the back film

3. Place the patch on the nail and remove it after about 6-8 hours

Warnings and Precautions (34071-1)

Keep out of reach of children.Avoid contact with eyes.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)

Keep out of reach of children.

Section 50566-9 (50566-9)

Discontinue use if signs of irritation or rash occur.

Section 50567-7 (50567-7)

1. Wash and dry affected nails before going to bed

2. Open the package, take out the patch and tear off the back film

3. Place the patch on the nail and remove it after about 6-8 hours

Section 50570-1 (50570-1)

Discontinue use if signs of irritation or rash occur.

Section 51727-6 (51727-6)

AQUA、GLYCERIN、ALLANTOIN

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

1. A variety of moisturizing ingredients are absorbed into nails and skin through the patch, deeply nourishing, hydrating brittle nails, and reducing the appearance of thick and discolored nails.

2. Replenish nails with necessary moisture and nutrients, quickly reduce brittle manicure overnight, and restore manicure to show its natural, healthy appearance.

3. Hygienic material support, soft and strong, can provide gentle repair to nails.

4. The packaging is compact and easy to use. The patch design is suitable for carrying when going out and can be used anytime and anywhere.

Section 55106-9 (55106-9)

SOPHORA ANGUSTIFOLIA ROOT EXTRACT、ALOE BARBADENSIS EXTRACT

Advanced Ingredient Data

[{"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "IACT", "strengthNumerator": "0.06", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "ALOE BARBADENSIS LEAF", "unii": "ZY81Z83H0X", "classCode": "ACTIB", "strengthNumerator": "0.012", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "3", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "AQUA", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "56.916", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "SOPHORA FLAVESCENS ROOT", "unii": "IYR6K8KQ5K", "classCode": "ACTIB", "strengthNumerator": "0.012", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "1. Wash and dry affected nails before going to bed 2. Open the package, take out the patch and tear off the back film 3. Place the patch on the nail and remove it after about 6-8 hours", "34068-7": "1. Wash and dry affected nails before going to bed 2. Open the package, take out the patch and tear off the back film 3. Place the patch on the nail and remove it after about 6-8 hours", "34071-1": "Keep out of reach of children.Avoid contact with eyes.Discontinue use if signs of irritation or rash occur.Store in a cool and dry place.", "44425-7": "Store in a cool and dry place.", "50565-1": "Keep out of reach of children.", "50566-9": "Discontinue use if signs of irritation or rash occur.", "50567-7": "1. Wash and dry affected nails before going to bed 2. Open the package, take out the patch and tear off the back film 3. Place the patch on the nail and remove it after about 6-8 hours", "50570-1": "Discontinue use if signs of irritation or rash occur.", "51727-6": "AQUA、GLYCERIN、ALLANTOIN", "55105-1": "1. A variety of moisturizing ingredients are absorbed into nails and skin through the patch, deeply nourishing, hydrating brittle nails, and reducing the appearance of thick and discolored nails. 2. Replenish nails with necessary moisture and nutrients, quickly reduce brittle manicure overnight, and restore manicure to show its natural, healthy appearance. 3. Hygienic material support, soft and strong, can provide gentle repair to nails. 4. The packaging is compact and easy to use. The patch design is suitable for carrying when going out and can be used anytime and anywhere.", "55106-9": "SOPHORA ANGUSTIFOLIA ROOT EXTRACT、ALOE BARBADENSIS EXTRACT"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:15.720272 · Updated: 2026-03-14T23:12:26.991151