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Get-gone - acne body cleanser - Medication Information

Product NDC Code 83010-011
Drug Name

Get-gone - acne body cleanser

Type Brand
Active Ingredients
Salicylic acid 20 mg/ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 562600
Application Number M006
Labeler Name Maelys Cosmetics, LTD
Packages
Package NDC Code Description
83010-011-00 1 bottle in 1 carton (83010-011-00) / 200 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 • In the shower, lather with water. • Massage all over wet skin, paying special attention to areas with acne. • Rinse thoroughly.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Water, Decyl Glucoside, Lauryl Glucoside, Sodium Cocoyl isethionate, Cocamidopropyl Betaine, PEG-150 Distearate, Sodium Cocoamphoacetate, Panthenol, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Salix Alba (Willow) Bark Extract, pilobium Fleischeri Flower/Leaf/Stem Extract, Chamomilla Recutita (Matricaria) Flower Extract, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Leaf Oil, Glycerin, Coconut Acid, Sodium Chloride, Sodium Cocoyl Glutamate, Sodium Lauryl Glucose Carboxylate, Parfum (Fragrance), Chlorphenesin, Disodium EDTA, Phenoxyelhanol, 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

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.
Get-Gone - Acne Body Cleanser SALICYLIC ACID WATER DECYL GLUCOSIDE LAURYL GLUCOSIDE SODIUM COCOYL ISETHIONATE COCAMIDOPROPYL BETAINE PEG-150 DISTEARATE SODIUM COCOAMPHOACETATE PANTHENOL HAMAMELIS VIRGINIANA LEAF MELALEUCA ALTERNIFOLIA LEAF SALIX ALBA BARK CHAMOMILE LAVENDER OIL PEPPERMINT GLYCERIN COCONUT ACID SODIUM CHLORIDE SODIUM COCOYL GLUTAMATE CHLORPHENESIN EDETATE DISODIUM ANHYDROUS PHENOXYETHANOL 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: 011

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 Protect this product from excessive heat and direct sun.

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. • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. • Do not get into eyes. tt excessive skin irritation develops or increases, discontinue use and consult a doctor. • If product is 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.
Question or Comments: 1-800-253-1983

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. Keep out of reach of children. • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. • Do not get into eyes. tt excessive skin irritation develops or increases, discontinue use and consult a doctor. • If product is 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