SPL v1
SPL
SPL Set ID 21307c5d-d34f-b95a-e063-6394a90a478f
Route
TOPICAL
Published
Effective Date 2022-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Centella Asiatica (10 mg)
Inactive Ingredients
Sodium Hydroxide

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-09-01

Description

Titrated Ext. of Centella Asiatica


Medication Information

Warnings and Precautions

Warnings

For external use only.

Do not use in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator.

Ask a doctor before use if you have a vaginal discharge, rectal bleeding, diaper rash.

When using this product consult a doctor before exceeding recommended dosage.

Stop use and ask a doctor if condition gets worse, condition persists for more than 7 days, condition clears up and occurs again with within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily

Dosage and Administration

for topical use

Description

Titrated Ext. of Centella Asiatica

Section 50565-1

Keep out of reach of children

Section 51727-6

Lavender oil, anhydrous ethanol, sodium hydroxide, purified water, propylene glycol.

Section 51945-4

Section 55105-1

temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, or poison sumac soaps detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, external genital and anal itching

Section 55106-9

Titrated Ext. of Centella Asiatica


Structured Label Content

Indications and Usage (34067-9)

Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily

Dosage and Administration (34068-7)

for topical use

Warnings and Precautions (34071-1)

Warnings

For external use only.

Do not use in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator.

Ask a doctor before use if you have a vaginal discharge, rectal bleeding, diaper rash.

When using this product consult a doctor before exceeding recommended dosage.

Stop use and ask a doctor if condition gets worse, condition persists for more than 7 days, condition clears up and occurs again with within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Lavender oil, anhydrous ethanol, sodium hydroxide, purified water, propylene glycol.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, or poison sumac soaps detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, external genital and anal itching

Section 55106-9 (55106-9)

Titrated Ext. of Centella Asiatica


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)