24 Hour Acne Serum Gel
FDA Label NDC 83286-007
11 label sections · Submitted to the FDA by Drmtlgy, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Drmtlgy, Llc for the product 24 Hour Acne Serum (NDC 83286-007). 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 drug facts, active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Benzoyl Peroxide 5%
Purpose
Acne Medication
Use
For the treatment of acne.
Warnings
For external use only.
Sunburn Alert This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.
When using this product • avoid unnecessary sun exposure and use sunscreen. • avoid contact with eyes, lips and mouth. • avoid contact with hair and dyed products, 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Clean the skin thoroughly before applying this product. Apply a thin layer to affected area, avoiding the eye area. Use up to twice daily, not to exceed 8 pumps per day. Allow to absorb before applying additional products. If irritation or sensitivity develops, stop use and consult a physician.
Other Information
• Store at room temperature: 20°–25°C (68°–77°F)
Inactive Ingredient
Water, Glycolic Acid, Sclerotium Gum, Arnica Montana Flower Extract, Allantoin, Echinacea Purpurea Extract, Hydrastis Canadensis (Goldenseal) Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Calendula Officinalis Flower Extract, Glycerin, Gluconolactone, Sodium Benzoate, Tetrasodium EDTA, Sodium Hydroxide
Questions Or Comments?
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Packaging
24hracneserum (83286007 2)
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