Active Ingredients
Salicylic Acid 2%
Byoma Acne Treatment Spot Paste
FDA Label NDC 84821-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Byoma Ltd for the product Byoma Acne Treatment Spot (NDC 84821-008). 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 ingredients, purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne Treatment
Use
- for the treatment of acne
Warnings
For external use only
When Using This Product
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
Stop Use And Ask A Doctor If
- skin irritation occurs or gets worse.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Centre right away.
Directions
- Clean the skin thoroughly before applying this product
- Cover the entire affected area with a thin layer one to 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.
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Aqua (Water), Kaolin, Diatomaceous Earth, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Ethyl Linoleate, Phenoxyethanol, Propanediol, Kojic Acid, Glycine Soja (Soybean) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Camphor, Benzyl Alcohol, Sodium Stearoyl Glutamate, Sodium Hydroxide, Phytosphingosine, Ceramide NP, Xanthan Gum, Centella Asiatica Leaf Extract, Ethylhexylglycerin, Bakuchiol, Dehydroacetic Acid, Chlorophyllin-Copper Complex, Rutin, Glycerin, Hydroxycinnamic Acid, Maltodextrin, Sodium Benzoate, Potassium Sorbate.
Questions Or Comments?
Contact [email protected]
Product Labeling
1 (Spotpaste2)
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