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| Product NDC Code | 70707-711 | ||||
|---|---|---|---|---|---|
| Drug Name | Acne face and body wash |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SHAMPOO, SUSPENSION | ||||
| RxCUI drug identifier | 845836 | ||||
| Application Number | M006 | ||||
| Labeler Name | Face Reality Skin Care, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzoyl Peroxide 2.5% Purpose For the treatment of Acne.
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: Use 1 to 3 times daily on affected skin, work into lather, rinse off thoroughly.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Purified Water, Ammonium Lauryl Sulfate, Glycerin, Disodium Cocoamphodiacetate, Propylene Glycol, Carbomer, Sodium Hydroxide, 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.Uses Adults and children 12 years and over: For the treatment of acne. For acne-prone or oily skin.
Purpose
Information about the drug product’s indications for use.Purpose For the treatment of Acne.
Spl product data elements
Usually a list of ingredients in a drug product.Acne Face and Body Wash BENZOYL PEROXIDE WATER AMMONIUM LAURYL SULFATE GLYCERIN DISODIUM COCOAMPHODIACETATE PROPYLENE GLYCOL CARBOXYPOLYMETHYLENE SODIUM HYDROXIDE BENZOYL PEROXIDE BENZOYL PEROXIDE
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.Package Labeling: Acne Face 01
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
Other Information May bleach hair or fabrics. Store at room temperature. Keep away from heat or direct sunlight.
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.Do not use this medication if you have very sensitive skin or if you are sensitive to benzoly peroxide.
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.
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 and eyelids. This product may cause irritation. Mild irritation may be reduced by using the product less frequently. If irritation becomes severe, discontinue use and consult a doctor. Do not use this medication if you have very sensitive skin or if you are sensitive to benzoly peroxide. 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