Gentle Acne Cleanser Liquid
FDA Label NDC 83286-013
Full FDA labeling including 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 Gentle Acne Cleanser (NDC 83286-013). 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, inactive ingredients, 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%
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
• Apply cleanser over wet face and work into lather. Rinse with water and pat dry. Can be used twice daily or as directed by physician. If excessive drying, or peeling occurs, reduce application to once daily.
Inactive Ingredients
Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Disodium Laureth Sulfosuccinate, Glycol Distearate, Yeast Extract, Salvia Sclarea (Clary) Extract, Kaempferia Galanga Root Extract, Triticum Vulgare (Wheat) Germ Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Olea Europaea (Olive) Leaf Extract, Hedera Helix (Ivy) Leaf/Stem Extract, Arctium Lappa Root Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Aurantifolia (Lime) Oil, Zingiber Officinale (Ginger) Root Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Mentha Piperita (Peppermint) Oil, Panthenol, Niacinamide, Glycerin, Menthol, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA
Packaging
Gentle Acne Cleanser (83286013 1)
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