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Acne moisturizer - Medication Information

Product NDC Code 68062-9907
Drug Name

Acne moisturizer

Type Brand
Active Ingredients
Salicylic acid .5 mg/50ml
Route TOPICAL
Dosage Form CREAM
Application Number M006
Labeler Name Spa de Soleil
Packages
Package NDC Code Description
68062-9907-1 45 ml in 1 jar (68062-9907-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Purpose Salicylic Acid (1.0%)..........Acne Treatment

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
For treatment of acne

Purpose

Information about the drug product’s indications for use.
Purpose Acne Treatment

Spl product data elements

Usually a list of ingredients in a drug product.
Acne Moisturizer salicylic acid WATER CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE CETYL ALCOHOL SALICYLIC ACID SALICYLIC ACID GLYCERIN OLIVE OIL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PL ACNE MOISTURIZER FDA

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
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.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API