SPL v1
SPL
SPL Set ID 3915aba8-6d91-6cb9-e063-6394a90aa607
Route
TOPICAL
Published
Effective Date 2025-07-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Centella Asiatica Leaf (0.99 mg) Salicylic Acid (0.07 mg) Azelaic Acid (0.002 mg) Quaternium-73 (0.003 mg)
Inactive Ingredients
Propylene Glycol Centella Asiatica Edetate Disodium Ethylhexylglycerin Panthenol Matricaria Chamomilla Niacinamide Phenoxyethanol Camellia Sinensis Leaf Water Peg-40 Hydrogenated Castor Oil 1,2-hexanediol Triethanolamine Cyclodextrin Arginine Allantoin Rosmarinus Officinalis (rosemary) Leaf Oil Hydroxyacetophenone Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Butylene Glycol Scutellaria Baicalensis Root Glycerin Polygonum Cuspidatum Root Glycyrrhiza Glabra Whole Fragrance Musky Floral Orc1600904

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-04

Description

clean the skin thoroughly before applying this product cover the entire affected area with a thin layer one or three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.


Medication Information

Warnings and Precautions

For external use only

Do not use

if you have very sensitive skin

if you are sensitive to benzoyl peroxide

Stop use and ask a doctor if

irritation becomes severe

Indications and Usage
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one or three times daily

because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Dosage and Administration

for the treatment of acne

Description

clean the skin thoroughly before applying this product cover the entire affected area with a thin layer one or three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Section 50565-1

If swallowed, get medical help or contact Poison Control Center right away.

Section 51727-6

WATER

PROPYLENE GLYCOL

GLYCERIN

NIACINAMIDE

HYDROXYACETOPHENONE

1,2-HEXANEDIOL

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

TRIETHANOLAMINE

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

PANTHENOL

BUTYLENE GLYCOL

CENTELLA ASIATICA EXTRACT

SCUTELLARIA BAICALENSIS ROOT EXTRACT

POLYGONUM CUSPIDATUM ROOT EXTRACT

CAMELLIA SINENSIS LEAF EXTRACT

KANZOU EKISU

CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT

HYDROXYPROPYL CYCLODEXTRIN

ARGININE

ALLANTOIN

DISODIUM EDTA

PEG-40 HYDROGENATED CASTOR OIL

FRAGRANCE

Section 51945-4

Section 55105-1

Evens skin tone & fades spots.

Balances oil & prevents breakouts.

Section 55106-9

QUATERNIUM-73 --------0.003%

CENTELLA ASIATICA LEAF EXTRACT --------0.99%

SALICYLIC ACID --------0.07%

AZELAIC ACID --------0.002%


Structured Label Content

Indications and Usage (34067-9)
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one or three times daily

because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Dosage and Administration (34068-7)

for the treatment of acne

Warnings and Precautions (34071-1)

For external use only

Do not use

if you have very sensitive skin

if you are sensitive to benzoyl peroxide

Stop use and ask a doctor if

irritation becomes severe

Section 50565-1 (50565-1)

If swallowed, get medical help or contact Poison Control Center right away.

Section 51727-6 (51727-6)

WATER

PROPYLENE GLYCOL

GLYCERIN

NIACINAMIDE

HYDROXYACETOPHENONE

1,2-HEXANEDIOL

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

TRIETHANOLAMINE

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

PANTHENOL

BUTYLENE GLYCOL

CENTELLA ASIATICA EXTRACT

SCUTELLARIA BAICALENSIS ROOT EXTRACT

POLYGONUM CUSPIDATUM ROOT EXTRACT

CAMELLIA SINENSIS LEAF EXTRACT

KANZOU EKISU

CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT

HYDROXYPROPYL CYCLODEXTRIN

ARGININE

ALLANTOIN

DISODIUM EDTA

PEG-40 HYDROGENATED CASTOR OIL

FRAGRANCE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Evens skin tone & fades spots.

Balances oil & prevents breakouts.

Section 55106-9 (55106-9)

QUATERNIUM-73 --------0.003%

CENTELLA ASIATICA LEAF EXTRACT --------0.99%

SALICYLIC ACID --------0.07%

AZELAIC ACID --------0.002%


Advanced Ingredient Data


Raw Label Data

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