SPL v1
SPL
SPL Set ID 31c7b6f2-9256-8c69-e063-6394a90a749c
Route
TOPICAL
Published
Effective Date 2025-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Azelaic Acid (12 mg)
Inactive Ingredients
Pentylene Glycol Allantoin Bisabolol Dipotassium Glycyrrhizate Glycyrrhiza Uralensis Root Rosmarinus Officinalis (rosemary) Leaf Oil Ethylhexyl Palmitate Peg-100 Stearate Sodium Carbonate Salicylic Acid Laureth-7 Mentha Piperita (peppermint) Oil Cetearyl Glucoside Water Propylene Glycol Polyacrylamide (1500 Mw) C13-14 Isoparaffin Dimethicone Glyceryl Stearate Sodium Hydroxide Phenoxyethanol Polygonum Cuspidatum Root Camellia Sinensis Leaf Matricaria Chamomilla Methylparaben Propylparaben Edetate Disodium Arginine Glycyrrhiza Glabra (licorice) Root Cetearyl Alcohol Centella Asiatica Root Hydroxyphenyl Propamidobenzoic Acid Scutellaria Baicalensis Root Cyclodextrin Caprylic/capric Triglyceride Butylene Glycol Polyacrylate Crosspolymer-6 Ethylhexylglycerin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-02

Description

For external use only, avoid the eye area. Avoid direct sunlight during use. Discontinue use immediately if irritation occurs. Store in a cool, dry place.


Medication Information

Warnings and Precautions

For external use only, avoid the eye area. Avoid direct sunlight during use.

Discontinue use immediately if irritation occurs. Store in a cool, dry place.

Indications and Usage

Apply a thin layer to cleansed face or affected areas morning and evening. Avoid the eye area. Use

sunscreen during the day.

Dosage and Administration

When using this product, avoid contact with eyes. If contact occurs,

rinse thoroughly with water. Discontinve use if any irritation or adverse reaction occurs.

Description

For external use only, avoid the eye area. Avoid direct sunlight during use. Discontinue use immediately if irritation occurs. Store in a cool, dry place.

Section 50565-1

Keep out of reach of children.

Section 51727-6

WATER

PROPYLENE GLYCOL

CAPRYLIC/CAPRIC TRIGLYCERIDE

ETHYLHEXYL PALMITATE

CETEARYL ALCOHOL

CETEARYL GLUCOSIDE

POLYACRYLAMIDE

C13-14 ISOPARAFFIN

LAURETH-7

DIMETHICONE

GLYCERYL STEARATE

PEG-100 STEARATE

SODIUM HYDROXIDE

SODIUM CARBONATE

POLYACRYLATE CROSSPOLYMER-6

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

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

PENTYLENE GLYCOL

HYDROXYPHENYL PROPAMIDOBENZOIC ACID

METHYLPARABEN

ALLANTOIN

BISABOLOL

PROPYLPARABEN

DIPOTASSIUM GLYCYRRHIZATE

GLYCYRRHIZA URALENSIS (LICORICE) ROOT EXTRACT

MENTHA PIPERITA (PEPPERMINT) OIL

DISODIUM EDTA

HYDROXYPROPYL CYCLODEXTRIN

SALICYLIC ACID

ARGININE

Section 51945-4

Section 55105-1

Evens skin tone & fades spots.

Balances oil & prevents breakouts.

Section 55106-9

AZELAIC ACID ----12%


Structured Label Content

Indications and Usage (34067-9)

Apply a thin layer to cleansed face or affected areas morning and evening. Avoid the eye area. Use

sunscreen during the day.

Dosage and Administration (34068-7)

When using this product, avoid contact with eyes. If contact occurs,

rinse thoroughly with water. Discontinve use if any irritation or adverse reaction occurs.

Warnings and Precautions (34071-1)

For external use only, avoid the eye area. Avoid direct sunlight during use.

Discontinue use immediately if irritation occurs. Store in a cool, dry place.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

WATER

PROPYLENE GLYCOL

CAPRYLIC/CAPRIC TRIGLYCERIDE

ETHYLHEXYL PALMITATE

CETEARYL ALCOHOL

CETEARYL GLUCOSIDE

POLYACRYLAMIDE

C13-14 ISOPARAFFIN

LAURETH-7

DIMETHICONE

GLYCERYL STEARATE

PEG-100 STEARATE

SODIUM HYDROXIDE

SODIUM CARBONATE

POLYACRYLATE CROSSPOLYMER-6

PHENOXYETHANOL

ETHYLHEXYLGLYCERIN

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

PENTYLENE GLYCOL

HYDROXYPHENYL PROPAMIDOBENZOIC ACID

METHYLPARABEN

ALLANTOIN

BISABOLOL

PROPYLPARABEN

DIPOTASSIUM GLYCYRRHIZATE

GLYCYRRHIZA URALENSIS (LICORICE) ROOT EXTRACT

MENTHA PIPERITA (PEPPERMINT) OIL

DISODIUM EDTA

HYDROXYPROPYL CYCLODEXTRIN

SALICYLIC ACID

ARGININE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Evens skin tone & fades spots.

Balances oil & prevents breakouts.

Section 55106-9 (55106-9)

AZELAIC ACID ----12%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)