SPL v2
SPL
SPL Set ID 3fd47677-52c9-6d43-e063-6294a90aa45b
Route
TOPICAL
Published
Effective Date 2025-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tea Tree Oil (0.18 mg)
Inactive Ingredients
Edetate Disodium Aqua Salicylic Acid Glycerin Sodium Polyacrylate (2500000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-28

Description

TEA TREE OIL


Medication Information

Warnings and Precautions

For external use only, 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. It is normal to find bubbles in the colloid.

Indications and Usage

1.Wash affected area and dry thoroughly. 2 Apply patch. 3.After 24 hours,remove patch. 4.Repeat procedure every 24 hours for up to 14 days for tags removal and up to 12 weeks for warts, until the problem has resolved, 5.May not compress wart in warm water for 5 minutes to assist in removal. 6.Store unused tag patch in a cool, dry place.

Dosage and Administration

1.Wash affected area and dry thoroughly. 2 Apply patch. 3.After 24 hours,remove patch. 4.Repeat procedure every 24 hours for up to 14 days for tags removal and up to 12 weeks for warts, until the problem has resolved, 5.May not compress wart in warm water for 5 minutes to assist in removal. 6.Store unused tag patch in a cool, dry place.

Description

TEA TREE OIL

Section 44425-7

Store in a cool and dry place.

Section 50565-1

For external use only, Keep out of reach of children.

Section 50566-9

Discontinue use if signs of irritation or rash occur.

Section 50567-7

1.Wash affected area and dry thoroughly.

2 Apply patch.

3.After 24 hours,remove patch.

4.Repeat procedure every 24 hours for up to 14 days for tags removal and up to 12 weeks for warts, until the problem has resolved.

5.May not compress wart in warm water for 5 minutes to assist in removal.

6.Store unused tag patch in a cool, dry place.

Section 50570-1

Discontinue use if signs of irritation or rash occur.

Section 51727-6

AQUA、GLYCERIN、SODIUM POLYACRYLATE (2500000 MW)、EDETATE DISODIUM、SALICYLIC ACID

Section 51945-4

Section 55105-1

Clear The Skin Tag

Section 55106-9

TEA TREE OIL


Structured Label Content

Indications and Usage (34067-9)

1.Wash affected area and dry thoroughly. 2 Apply patch. 3.After 24 hours,remove patch. 4.Repeat procedure every 24 hours for up to 14 days for tags removal and up to 12 weeks for warts, until the problem has resolved, 5.May not compress wart in warm water for 5 minutes to assist in removal. 6.Store unused tag patch in a cool, dry place.

Dosage and Administration (34068-7)

1.Wash affected area and dry thoroughly. 2 Apply patch. 3.After 24 hours,remove patch. 4.Repeat procedure every 24 hours for up to 14 days for tags removal and up to 12 weeks for warts, until the problem has resolved, 5.May not compress wart in warm water for 5 minutes to assist in removal. 6.Store unused tag patch in a cool, dry place.

Warnings and Precautions (34071-1)

For external use only, 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. It is normal to find bubbles in the colloid.

Section 44425-7 (44425-7)

Store in a cool and dry place.

Section 50565-1 (50565-1)

For external use only, 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 affected area and dry thoroughly.

2 Apply patch.

3.After 24 hours,remove patch.

4.Repeat procedure every 24 hours for up to 14 days for tags removal and up to 12 weeks for warts, until the problem has resolved.

5.May not compress wart in warm water for 5 minutes to assist in removal.

6.Store unused tag patch in a cool, dry place.

Section 50570-1 (50570-1)

Discontinue use if signs of irritation or rash occur.

Section 51727-6 (51727-6)

AQUA、GLYCERIN、SODIUM POLYACRYLATE (2500000 MW)、EDETATE DISODIUM、SALICYLIC ACID

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Clear The Skin Tag

Section 55106-9 (55106-9)

TEA TREE OIL


Advanced Ingredient Data


Raw Label Data

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