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Acne cleanser - Medication Information

Product NDC Code 68062-9905
Drug Name

Acne cleanser

Type Brand
Active Ingredients
Salicylic acid 1.15 mg/230ml
Route TOPICAL
Dosage Form LIQUID
Application Number M006
Labeler Name Spa de Soleil
Packages
Package NDC Code Description
68062-9905-1 240 ml in 1 bottle (68062-9905-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Purpose Salicylic Acid (0.5%)..........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: Wash affected area twice daily.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Other Ingredients: Aqua, Sodium Methyl 2-Sulfolaurate, Disodium 2-Sulfolaurate, Glycerin, Ethoxydiglycol, Hydroxyethylcellulose, Guar Hydroxypropyltrimonium Chloride, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Sodium Hyaluronate (Hyaluronic Acid), Sodium Hydroxide, *CO Glycerin, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Benzyl Alcohol, Dehydroacetic Acid, Fragrance. *CO Certified 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 Cleanser salicylic acid SODIUM METHYL 2-SULFOLAURATE DISODIUM 2-SULFOLAURATE WATER SALICYLIC ACID SALICYLIC ACID GLYCERIN

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 Cleanser 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