Active Ingredient
Salicylic Acid 2%
Skinmedica Acne Clarifying Treatment Lotion
FDA Label NDC 0023-1230
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allergan, Inc. for the product Skinmedica Acne Clarifying Treatment (NDC 0023-1230). 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 active ingredient, purpose, uses, warnings, when using this product:, 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
Purpose
Acne Treatment
Uses
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.
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 with a thin layer one to three times daily.
- 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.
- 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 Information
Store at room temperature
Inactive Ingredients
Water, Tridecyl Salicylate, Cocamidopropyl Dimethylamine, Propanediol, Arachidyl Alcohol, Niacinamide, Di‐C12‐13 Alkyl Malate, Glycerin, Polyacrylate‐13, Butylene Glycol, Behenyl Alcohol, Bakuchiol, Baicalin, Potassium Lauroyl Wheat Amino Acids, Palmitoyl Tripeptide‐8, Centella Asiatica Extract, Magnolia Grandiflora Bark Extract, Physalis Pubescens Fruit Juice, Narcissus Tazetta Bulb Extract, Taraktogenos Kurzii Seed Oil, Nigella Sativa Seed Oil, Leptospermum Scoparium Branch/Leaf Oil, Saccharide Isomerate, Palm Glycerides, Capryloyl Glycine, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Tocopherol, Polysorbate 20, Arachidyl Glucoside, Polyisobutene, Methyl Methacrylate Crosspolymer, Dextran, Xanthan Gum, Aminomethyl Propanol, Potassium Sorbate, Ethylhexylglycerin, Phenoxyethanol, Disodium EDTA
Questions Or Comments
www.skinmedica.com
Principal Display Panel - Carton
NDC 0023-1230-01
SkinMedica
ACNE CLARIFYING TREATMENT
2% SALICYLIC ACID
ACNE TREATMENT
WITH NIACINAMIDE
2 Fl. Oz. / 60 ml
Principal Display Panel (CartonNDC 0023-1230-01SkinMedicaACNE CLARIFYING TREATMENT2% SALICYLIC ACIDACNE TREATMENTWITH NIACINAMIDE2 Fl. Oz. / 60 ml)
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