Otc - Active Ingredient
Benzoyl Peroxide 4%
Bellamiluxx Body Acne Cleanser Lotion
FDA Label NDC 87205-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bellamiluxx Llc for the product Bellamiluxx Body Acne Cleanser (NDC 87205-003). 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, dosage & administration, warnings, otc - keep out of reach of children, indications & usage, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Acne treatment
Dosage & Administration
For the treatment of acne.
Warnings
For external use only.
Do not use if you
- have very sensitive skin
- are sensitive benzoyl peroxide.
- 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.
- avoid unnecessary sun exposure and use a sunscreen.
- avoid contact with the eyes, lips, and mouth
- avoid contact with hair and dyed fabrics, which may be bleached by this product
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
When using this product
Stop use and ask a doctor if irritation becomes severe.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poision Control Center right away.
Indications & Usage
- Clean the skin thoroughly before applying this product.
- Take an appropriate amount and foam enough on your body then wash off with water.
- 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 applicationto once a day or every other day.
- If going outside, apply sunscreen after using this product. Ifirritation or sensitivity develops, stop use of both products and ask a doctor.
Inactive Ingredient
Water, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betaine,Decyl Glucoside, Glycerin, Niacinamide, Butylene Glycol,Panthenol, Phenoxyethanol, Centella Asiatica Extract, SodiumPCA, Allantoin, Ceramide NP, Carbomer, Polyquaternium-7,Bisabolol, Ethylhexylglycerin, Triethanolamine, Xanthan Gum,Disodium EDTA, Tocopheryl Acetate
Otc - Questions
Email: [email protected]
Visit: www.bellamiluxx.com
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