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| Product NDC Code | 49527-061 | ||||
|---|---|---|---|---|---|
| Drug Name | Blackhead solutions self-heating blackhead extractor acne medication |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 417424 | ||||
| Application Number | M006 | ||||
| Labeler Name | CLINIQUE LABORATORIES LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic Acid 1.0%
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 3 times a week on clean, dry skin. Unscrew top to dispense product. Apply thin layer on blackhead-prone areas. Reattach top. Wet product on skin to activate heat. Massage 15-30 seconds with applicator tip, then rinse.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients magnesium sulfate • dimethicone • isononyl isononanoate • isododecane • polysilicone-11 • phenyl trimethicone • hydrogenated lecithin • acetyl glucosamine • polysorbate 20 • polysorbate 80 • polyethylene • diatomaceous earth\solum diatomeae\terre de diatomées • triethylhexanoin • pumice • bambusa arundinacea (bamboo) stem extract • peg-15/lauryl dimethicone crosspolymer • caprylyl glycol • stearyl glycyrrhetinate • water\aqua\eau • silica [iln43644]
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 reduces the number of blackheads helps keep skin clear of new blackheads helps prevent development of new blackheads
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.blackhead solutions self-heating blackhead extractor acne medication Salicylic acid DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) BAMBUSA BAMBOS STEM MAGNESIUM SULFATE, UNSPECIFIED FORM DIMETHICONE ISONONYL ISONONANOATE ISODODECANE PHENYL TRIMETHICONE HYDROGENATED SOYBEAN LECITHIN N-ACETYLGLUCOSAMINE POLYSORBATE 20 POLYSORBATE 80 HIGH DENSITY POLYETHYLENE DIATOMACEOUS EARTH TRIETHYLHEXANOIN PUMICE CAPRYLYL GLYCOL STEARYL GLYCYRRHETINATE WATER SILICON 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 - 20 ml Tube Carton blackheads CLINIQUE blackhead solutions self-heating blackhead extractor SALICYLIC ACID ACNE MEDICATION ALL SKIN TYPES .68 FL.OZ.LIQ./20 ml e Principal Display Panel
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
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 product is swallowed, get medical help or contact a Poison Control Center right away. Keep out of eyes.
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 at the same time. If irritation occurs, only one topical acne medication should be used unless directed by a doctor.
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 skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only one topical acne medication should be used unless directed by a doctor. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Keep out of eyes.
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