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Breakout clearing booster - Medication Information

Product NDC Code 68479-772
Drug Name

Breakout clearing booster

Type Brand
Active Ingredients
Salicylic acid 2 mg/100ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 251577
Application Number part333D
Labeler Name Dermalogica, Inc.
Packages
Package NDC Code Description
68479-772-00 2 ml in 1 pouch (68479-772-00)
68479-772-01 10 ml in 1 bottle (68479-772-01)
68479-772-02 1 bottle, dispensing in 1 carton (68479-772-02) / 30 ml in 1 bottle, dispensing
68479-772-05 4 ml in 1 tube (68479-772-05)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Salicylic Acid (2.0%) 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 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/Aqua/Eau, PPG-15 Stearyl Ether, Butylene Glycol, Glycerin, Isopropyl Lauroyl Sarcosinate, Niacinamide, Cetearyl Glucoside, 1,2-Hexanediol, Polysorbate 20, Hydroxyacetophenone, Chlorella Vulgaris Extract, Terpineol, Thymol, Chondrus Crispus (Carrageenan) Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Lactic Acid, Sodium Hyaluronate, Dimethicone, Xanthan Gum, Sclerotium Gum, Lecithin, Pullulan, Propanediol, Tetrasodium Glutamate Diacetate, Silica, Sodium Hydroxide, Sodium Citrate, Limonene.

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 Treatment

Spl product data elements

Usually a list of ingredients in a drug product.
BREAKOUT CLEARING BOOSTER Salicylic Acid Salicylic Acid Salicylic Acid Water POLYPROPYLENE GLYCOL 15 STEARYL ETHER Butylene Glycol Glycerin Isopropyl Lauroyl Sarcosinate Niacinamide Cetearyl Glucoside 1,2-Hexanediol Polysorbate 20 Hydroxyacetophenone Dimethicone Xanthan Gum BETASIZOFIRAN LECITHIN, SOYBEAN Propanediol SODIUM CITRATE, UNSPECIFIED FORM Pullulan CHONDRUS CRISPUS CITRUS SINENSIS FLOWER OIL Terpineol Thymol Tetrasodium Glutamate Diacetate SILICON DIOXIDE CHLORELLA VULGARIS LACTIC ACID, DL- HYALURONATE SODIUM Sodium Hydroxide LIMONENE, (+)-

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 Bottle Carton clears breakout causing bacteria in 15 minutes breakout clearing booster dermatologica clear start 1.0 US FL OZ / 30 mL e PRINCIPAL DISPLAY PANEL - 30 mL Bottle 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

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 In or near eyes. If contact occurs, flush thoroughly with water.

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 Call toll free 1-800-831-5150 in the US

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 Apply to affected areas only. Skin irritation and dryness are 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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information Protect this product from excessive heat and direct sun.

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 Do not use In or near eyes. If contact occurs, flush thoroughly with water. When using this product Apply to affected areas only. Skin irritation and dryness are 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. 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