The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Ariel Biotech Co., Ltd. for the product 10% Azelaic Acid Acne Cream (NDC 84148-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
AZELAIC ACID 10.00000%
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID 0.50000%
CAPRYLOYL GLYCINE 0.15000%
o-CYMEN-5-OL 0.09000%
MADECASSOSIDE 0.05500%
CENTELLA ASIATICA EXTRACT 0.03000%
LAVANDULA HYBRIDA OIL 0.03000%
ASIATICOSIDE 0.01500%
SAURURUS CHINENSIS LEAF/ROOT EXTRACT 0.01000%
TARAXACUM OFFICINALE (DANDELION) LEAF EXTRACT 0.01000%
STEPHANIA TETRANDRA EXTRACT 0.00160%
Acne treatment
①Treatments for acne.
②Reduces acne and blemishes.
③Evens skin tone & fades spots.
④Balances oil & prevents breakouts.
Apply a thin layer to cleansed face or affected areas morning and evening. Avoid the eye area. Use
sunscreen during the day.
WARNINGS:For external use only. avoid the eye area. Avoid direct sunlight during use.
Discontinue use immediately if rritation occurs. Store in a cool, dry place.
Stop using immediately if there is any stimulation
Discontinve use if any irritation or adverse reaction occurs.
For external use only, avoid the eye area. Avoid direct sunlight during use. Discontinue use immediately if rritation occurs. Store in a cool, dry place.
Keep out of reach of children.
Apply a thin layer to cleansed face or affected areas morning and evening. Avoid the eye area. Use sunscreen during the day.
No Data
WATER, AZEL AIC ACID, BUTYLENE GLYCOL, METHYLPROPANEDIOL, DIMETHICONE, CETEARYL GLUCOSIDE, DIPROPYLENE GLYCOL, SORBITAN OLIVATE, POLYACRYLATE-6, SQUAL ANE, CETYL ALCOHOL, HYDROXYPROPYL CYCLODEXTRIN, 1,2-HEXANEDIOL, 4-HYDROXYACETOPHENONE, HYDROXYETHYLPIPERAZINEETHANE SULFONIC ACID, STEARYL ALCOHOL, ALLANTOIN, CYCLODEXTRIN, CAPRYLOYL GLYCINE, XANTHAN GUM, O-CYMEN-5-OL, MADECASSOSIDE, CENTELLA ASIATICA EXTRACT, LAVANDULA ANGUSTIFOLIA OL, CENTELLA ASIATICA, SAURURUS CHINENSIS LEAF/ROOT EXTRACT, TARAXACUM OFFICINALE LEAF EXTRACT, STEPHANIA TETRANDRAE EXTRACT
Undefined (Label)
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