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Product NDC Code | 10237-001 | ||||
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Drug Name | Hero pore release blackhead clearing |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 251577 | ||||
Application Number | part333D | ||||
Labeler Name | Church & Dwight Co., Inc. | ||||
Packages |
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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 Cleanse 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/aqua/eau, butylene glycol, gluconolactone, arginine, glycolic acid, aloe barbadensis leaf juice, nelumbo nucifera root water, glycerin, hydrolyzed gardenia florida extract, biosaccharide gum-1, sodium levulinate, glyceryl caprylate, maltodextrin, sodium anisate, sodium hydroxide, potassium sorbate, sodium benzoate, citric acid
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 For the treatment of acne Reduces the number of blackheads Helps keep skin clear 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.Hero Pore Release Blackhead Clearing Salicylic Acid Salicylic Acid Salicylic Acid WATER BUTYLENE GLYCOL GLUCONOLACTONE ARGININE GLYCOLIC ACID ALOE VERA LEAF NELUMBO NUCIFERA ROOT OIL GLYCERIN BIOSACCHARIDE GUM-1 SODIUM LEVULINATE GLYCERYL MONOCAPRYLATE MALTODEXTRIN SODIUM ANISATE SODIUM HYDROXIDE POTASSIUM SORBATE SODIUM BENZOATE CITRIC ACID MONOHYDRATE Transparent liquid
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 - 100 ml Bottle Label Hero. PORE RELEASE Blackhead Clearing Solution 2% Salicylic Acid Acne Treatment with PHA, AHA, and Lotus Water 100 ml / 3.38 fl. oz. PRINCIPAL DISPLAY PANEL - 100 ml Bottle Label
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 Hero Cosmetics, Inc. New York, NY 10013
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 or comments? 347-669-0686
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 irritation becomes severe
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 use one topical acne medication at a time. avoid contact with eyes. If contact occurs, flush thoroughly with water.
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 use one topical acne medication at a time. avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if irritation becomes severe Sunburn Alert This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.
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