SPL v2
SPL
SPL Set ID 2f80ffc4-c945-71c9-e063-6394a90add8c
Route
TOPICAL
Published
Effective Date 2025-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camellia Sinensis Leaf (0.002 mg) Melaleuca Alternifolia (tea Tree) Leaf Oil (0.4 mg)
Inactive Ingredients
Glycerin Aqua Panthenol Pyrrolidone Carboxylic Acid Salicylic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-04

Description

AQUA, GLYCERIN, PANTHENOL 、SODIUM PCA、 SALICYLIC ACID


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.

Description

AQUA, GLYCERIN, PANTHENOL 、SODIUM PCA、 SALICYLIC ACID

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

1.Clean and dry the affected area.

2. Take an appropriate amount of essence.

3. Apply the essence to the surrounding skin.

4. Apply 2 times a day.

Section 50570-1

Discontinue use if signs of irritation or rash occur.

Section 51727-6

AQUA, GLYCERIN, PANTHENOL 、SODIUM PCA、 SALICYLIC ACID

Section 51945-4

Section 55105-1

Don't Be Embarrassed By Skin Tags.

Make Your Skin Smooth.

Section 55106-9

MELALEUCA ALTERNIFOLIA (TEA TREE)LEAF OIL、CAMELLIA SINENSIS LEAF


Structured Label Content

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)

1.Clean and dry the affected area.

2. Take an appropriate amount of essence.

3. Apply the essence to the surrounding skin.

4. Apply 2 times a day.

Section 50570-1 (50570-1)

Discontinue use if signs of irritation or rash occur.

Section 51727-6 (51727-6)

AQUA, GLYCERIN, PANTHENOL 、SODIUM PCA、 SALICYLIC ACID

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Don't Be Embarrassed By Skin Tags.

Make Your Skin Smooth.

Section 55106-9 (55106-9)

MELALEUCA ALTERNIFOLIA (TEA TREE)LEAF OIL、CAMELLIA SINENSIS LEAF


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)