Otc - Active Ingredient
Active ingredient Purpose
Salicylic Acid (1.0%)..........Acne Treatment
Acne Moisturizer Cream
FDA Label NDC 68062-9907
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 Moisturizer (NDC 68062-9907). 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, otc - when using, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Acne Treatment
Indications & Usage
For treatment of acne
Warnings
Warnings
For external use only
Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
If swallowed, get medical help or contact a Poison Control Center right away. If excessive skin irritation develops or increases, discontinue use and consult a doctor. Keep out of reach of children.
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.
Otc - When Using
When using this product
• Skin irritation and dryness is more likely to occur if you use another topical acne medication while using this product. If irritation occurs, use only one topical acne medication at a time.
Dosage & Administration
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 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:
Aqua, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Cetearyl Alcohol, Olea Europaea (Olive) Fruit Oil, Glyceryl Stearate SE, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Glucoside, Xanthan Gum, Tocopheryl Acetate (Vitamin E), Disodium EDTA, Avena Sativa (Oat) Kernel Flour, Caffeine, *CO Aloe Barbadensis Leaf Powder, Sodium Hyaluronate (Hyaluronic Acid), Ascorbic Acid (Vitamin C), Retinyl Palmitate (Vitamin A), Phenoxyethanol, Ethylhexylglycerin, Fragrance. *CO – Organic
* Please review the disclaimer below.
