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Pore release 2 salicylic acid acne treatment - Medication Information

Product NDC Code 73381-001
Drug Name

Pore release 2 salicylic acid acne treatment

Type Brand
Active Ingredients
Salicylic acid 20 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 251577
Application Number part333D
Labeler Name Hero Cosmetics, Inc.
Packages
Package NDC Code Description
73381-001-00 1 bottle in 1 box (73381-001-00) / 100 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Salicylic Acid 2% Purpose 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 • 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, 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 black heads

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.
Pore Release 2 Salicylic Acid Acne Treatment SALICYLIC ACID WATER BUTYLENE GLYCOL GLUCONOLACTONE ARGININE GLYCOLIC ACID ALOE VERA LEAF NELUMBO NUCIFERA ROOT OIL GLYCERIN BIOSACCHARIDE GUM-1 SODIUM LEVULINATE GLYCERYL CAPRYLATE MALTODEXTRIN SODIUM ANISATE SODIUM HYDROXIDE POTASSIUM SORBATE SODIUM BENZOATE CITRIC ACID MONOHYDRATE 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.
Package Labeling: Label0 innerlabel

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 swallowed, get medical help or conact 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 conact 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