SPL v1
SPL
SPL Set ID 641fbbe5-dd60-31e2-e053-2991aa0af804
Route
VAGINAL
Published
Effective Date 2017-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Centella Asiatica (15 g)
Inactive Ingredients
Aloe Vera Leaf Hamamelis Virginiana Leaf

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2018-01-01
Description

Centella Asiatica Extract

Medication Information

Warnings and Precautions

Precautions for Use

If any of the following conditions occur, discontinue use immediately and consult a dermatologist. Continuous use will cause symptoms to worsen.

1) In case of skin reaction such as red spots, swelling, itch or irritation etc. during use

2) In case of the above skin reaction when applied area is exposed to direct sunlight

Do not use on damaged skin area such as wound, rash or skin infection

Storage and Handling

1) Close lid tightly after use

2) Keep out of reach of infants and children

3) Store in a cool, dry place away from direct sunlight

4) Avoid eye area

Indications and Usage

With clean hands, dispense an appropriate amount and apply on skin, massaging gently

Dosage and Administration

for external use only



Description

Centella Asiatica Extract

Section 50565-1

keep out or reach of the children

Section 51727-6

Sodium Hyaluronate, Hamamelis Virginiana (Witch Hazel) Leaf Extract, etc.

Section 51945-4

Section 55105-1

Water-soluble massage gel

Section 55106-9

Centella Asiatica Extract

Structured Label Content

Indications and Usage (34067-9)

With clean hands, dispense an appropriate amount and apply on skin, massaging gently

Dosage and Administration (34068-7)

for external use only



Warnings and Precautions (34071-1)

Precautions for Use

If any of the following conditions occur, discontinue use immediately and consult a dermatologist. Continuous use will cause symptoms to worsen.

1) In case of skin reaction such as red spots, swelling, itch or irritation etc. during use

2) In case of the above skin reaction when applied area is exposed to direct sunlight

Do not use on damaged skin area such as wound, rash or skin infection

Storage and Handling

1) Close lid tightly after use

2) Keep out of reach of infants and children

3) Store in a cool, dry place away from direct sunlight

4) Avoid eye area

Section 50565-1 (50565-1)

keep out or reach of the children

Section 51727-6 (51727-6)

Sodium Hyaluronate, Hamamelis Virginiana (Witch Hazel) Leaf Extract, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Water-soluble massage gel

Section 55106-9 (55106-9)

Centella Asiatica Extract

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:29.985268 · Updated: 2026-03-14T22:55:00.598631