Otc - Active Ingredient
Benzoyl Peroxide 5%
Olivia Quido Acne Cream
FDA Label NDC 71421-902
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by O Skin Care Llc for the product Olivia Quido Acne Cream (NDC 71421-902). 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, uses, warnings, otc - 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.
Label Section Quick Index
Otc - Purpose
Acne Treatment
Uses
For the treatment of acne
Warnings
For external use only
Otc - Do Not Use
• Have very sensitive skin
• Are sensitive to Benzoyl Peroxide
Otc - When Using
• Skin irritation and dryness will likely 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 urinecessary 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.
Keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if irritation becomes severe
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
Directions
• Clean the skin thoroughly before applying this product
• Cover the entire affected area with a thin layer one to three times daily
Indications & Usage
• 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.
• If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
• Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
Other Safety Information
Other Information
• Protect from excessive heat and direct sunlight
• Store at controlled temperature: 15°C -30°C (59°F-86°F)
Inactive Ingredient
Inactive Ingredients
1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Water), C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Dipotassium Glycyrrhizate, Glycerin, Glyceryl Stearate, Hexyl Laurate, Laureth-7, Lecithin, Magnesium Sulfate, PEG-100 Stearate, Polyacrylamide, Polyglyceryl-4 Isostearate, Potassium Cetyl Phosphate, Potassium Sorbate, PPG-12/SMDI Copolymer, Silica, Sodium Acrylates Copolymer, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Titanium Dioxide, Tocopheryl Acetate.
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