Crystal Clear Acne Treatment Pads Patch
FDA Label NDC 83316-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skin Pharm, Llc for the product Crystal Clear Acne Treatment Pads (NDC 83316-001). 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
Salicylic acid 2% w/v
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 • avoid contact with eyes, lips and mouth. If contact occurs, flush thoroughly with water.
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 • cover the entire affected area one to two times daily, avoiding eye area • allow to absorb before applying additional products • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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 • do not rinse • tighten cap after use to prevent pads from drying out.
• Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first three days. If no discomfort occurs, follow the directions stated above.
Other Information
• store at 68° - 77° F • protect from excessive moisture
• 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.
Inactive Ingredients
Allantoin, Aloe (Aloe barbadensis) leaf extract, Beta-glucan, Caprylic/capric triglyceride, Chamomile (Chamomilla recutita) flower extract, Cucumber (Cucumis sativus) fruit extract, Dipotassium glycyrrhizate, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Glycolic acid, Grapefruit (Citrus grandis) peel extract, Lactic acid, Licorice (Glycyrrhiza glabra) root extract, Menthyl lactate, PEG-40 hydrogenated castor oil, Phenoxyethanol, PPG-26-Buteth-26, Sodium hydroxide, Tetrasodium EDTA, Water (Aqua), White mulberry (Morus alba) root extract
Questions?
+1-615-582-6726
You may also report serious side effects to this phone number.
Mon - Fri, 9:30 AM - 5:30 PM
Packaging
Acnepad001 (8331600101 3)
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