Otc - Active Ingredient
Active ingredient Purpose
Salicylic Acid (0.5%)..........Acne Medication
Acne Drying Lotion
FDA Label NDC 68062-9003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spa De Soleil for the product Acne Drying (NDC 68062-9003). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Acne Medication
Indications & Usage
Use for the management of acne
Warnings
Warnings: For external use only. Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Sensitivity test for new users: Apply product sparingly to one or two small affected areas during the first three days. If no discomfort occurs, follow the steps stated in directions.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions: Cleanse skin thoroughly before applying medication . Cover the entire affected area with a thin layer one to two times daily. 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.
Inactive Ingredient
Other ingredients: Isopropyl Alcohol, Aqua, Calamine, Aluminum Starch Octenylsuccinate, Zinc Oxide, Glycerin, Camphor, Colloidal Sulfur, *CO Glycerin, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract.
*CO Certified Organic
* Please review the disclaimer below.
