Otc - Active Ingredient
14%Azelaic Acid
Bloomellee 14%gel Azelaic Acid Cream
FDA Label NDC 87386-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Lanxi Trading Co., Ltd. for the product Bloomellee 14%gel Azelaic Acid Cream (NDC 87386-002). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Acne Cream
Indications & Usage
Clear Skin Solution
Fade Acne Marks
Soothing & Oil Control
Apply proper amount to facial acne gently after morning and night cleansing, massage until absorbed.
Warnings
For external use only.
Otc - When Using
Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Discontinue use if irritation occurs. If irritation persists, consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions: After cleaning your face, apply an appropriate amount of this product to your face and genty massage with your fingertips, focusing on the areas around the pimples until fully absorbed.
Inactive Ingredient
Water, Propylene Glycol, Ethylhexyl Palmitate, Glycerin, Cetearyl Alcohol, Mineral Oil, Lauric/myristic/palmitic/stearic Glycerides, Glyceryl Stearate, Butylene Glycol, Totarol, Dimethicone, 0 -cymen-5-ol, PolyacrylamideC13-14 Isoparaffin, Laureth-7, Ceteareth-25, Beeswax, Hydroxyacetophenone, Allantoin, Carbomer, Triethanolamine, Xanthan Gum, Phenoxyethanol, Caprylhydroxamic Acid, Disodium Edta, Fragrance, Dipotassium Glycyrhizate, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Polygonum Cuspidatum Root Extract, Camellia Sinensis Leaf Extract, Kanzou Ekisu, Chamomila Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf ExtractBacillus/soybean Ferment Extract, Folic Acid, 1,2-hexanediol, Sodium Hyaluronate, Jania Rubens Extract
Package Label.Principal Display Panel
Label1 (Label1)
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