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| Product NDC Code | 68062-2267 | ||||
|---|---|---|---|---|---|
| Drug Name | Acne care lotn |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M006 | ||||
| Labeler Name | Spa de Soleil | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Purpose Salicylic Acid (0.5%)..........Acne Treatment Sulfur (2.0%)......................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, PEG – 100 Stearate, Glyceryl Stearate, Glycerin, Stearic Acid, Cetyl Alcohol, Titanium Dioxide, Butylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Zinc Oxide, Hydroxyethyl Cellulose, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Chloroxylenol, Tocopheryl Acetate (Vitamin E), Ascorbic Acid (Vitamin C), Malus Domestica (Apple) Fruit Cell Culture Extract, Citric Acid, Lactic Acid, Malic Acid, Gluconic Acid, Glycolic Acid, Salicylic Acid, Tartaric Acid, *CO Alcohol, *CO Glycerin, *CO Salix Alba Bark Extract, *CO Avena Sativa (Oat) Kernel Extract, *CO Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, *CO Pogostemon Cablin Oil, *CO Melaleuca Alternifolia (Tea Tree) Leaf Oil, Disodium EDTA, Sea Salt, **Squalane, Fragrance.
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 Care Lotn salicylic acid PEG-100 STEARATE GLYCERYL STEARATE/PEG-100 STEARATE GLYCERIN SALICYLIC ACID SALICYLIC ACID STEARIC ACID D7 CETYL ALCOHOL SULFUR SULFUR WATER
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 Lotion 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