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| Product NDC Code | 63824-347 | ||||
|---|---|---|---|---|---|
| Drug Name | Clearasil ultra acne plus marks spot |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 103568, 1049425 |
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| Application Number | M006 | ||||
| Labeler Name | RB Health (US) LLC | ||||
| 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 Salicylic acid 2%
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.Inactive ingredients Water, Alcohol Denat., Octyldodecanol, Dimethicone, Niacinamide, Sodium Lactate, Isohexadecane, Polyacrylamide, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Hexyldecanol, C13-14 Isoparaffin, Magnesium Aluminum Silicate, Fragrance, Laureth-7, Disodium EDTA, Dipotassium Glycyrrhizate, Bisabolol, Cetylhydroxyproline Palmitamide, Stearic Acid, Brassica Campestris (Rapeseed) Sterols, Titanium Dioxide
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.Use for the treatment of acne
Purpose
Information about the drug product’s indications for use.Purpose Acne Medication
Spl product data elements
Usually a list of ingredients in a drug product.Clearasil Ultra Acne Plus Marks Spot Salicylic Acid WATER OCTYLDODECANOL DIMETHICONE NIACINAMIDE SODIUM LACTATE ISOHEXADECANE SODIUM HYDROXIDE XANTHAN GUM HEXYLDECANOL C13-14 ISOPARAFFIN MAGNESIUM ALUMINUM SILICATE LAURETH-7 EDETATE DISODIUM LEVOMENOL STEARIC ACID TITANIUM DIOXIDE SALICYLIC ACID SALICYLIC ACID
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.PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton Clearasil ® ULTRA Acne + Marks Spot Lotion Salicylic Acid 2% Acne Medication REDUCES MARKS Helps to clear pimples fast and reduce the appearance of acne marks 1 FL. OZ. (30 mL) PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Distributed by: Reckitt Benckiser LLC Parsippany, NJ 07054-0224 Made in USA
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.For external use only
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. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-866-25-CLEAR (1-866-252-5327). You may also report side effects to this phone number.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if skin or eye irritation develops.
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 Avoid contact with eyes, lips and mouth. If contact occurs, rinse thoroughly with water Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time Limit use to the face and neck Wash hands after use Sun Alert: Because this product may make your skin more sensitive to the sun, be certain you have adequate sunscreen protection while using this product and for a week after you discontinue use
Storage and handling
Information about safe storage and handling of the drug product.Other information Keep tightly closed Store at 20-25°C (68-77°F)
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 When using this product Avoid contact with eyes, lips and mouth. If contact occurs, rinse thoroughly with water Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time Limit use to the face and neck Wash hands after use Sun Alert: Because this product may make your skin more sensitive to the sun, be certain you have adequate sunscreen protection while using this product and for a week after you discontinue use Stop use and ask a doctor if skin or eye irritation develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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