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| Product NDC Code | 83010-012 | ||||
|---|---|---|---|---|---|
| Drug Name | Get-back - targeted body acne |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 1048903 | ||||
| Application Number | M006 | ||||
| Labeler Name | Maelys Cosmetics, LTD | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 • Hold the tube with the nozzle facing down. • Spray an even layer directly to back acne. • Let it dry before getting dressed. • Use twice a day for best results.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water, Propanediol, Glycerin, Salix Alba (Willow) Bark Extract, Niacinamide, Rosmarinus Officinalis (Rosemary) Extract, Glycyrrhiza Glabra (Licorice) Root Extract. Citrus Limon (Lemon) Peel Extract, Citrus Grandis (Grapefruit) Seed Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Epilobium Fleischeri Flower/Leaf/Stem Extract, Panthenol, Tocopherol, Aloe Barbadensis Leaf Juice, PPG-1-PEG-9 Lauryl Glycol Ether, Coceth-7, Polydextrose, Dextrin, Amylopectin, PEG-40 Hydrogenated Castor Oil, Parfum (Fragrance), Zinc PCA, Ethylhexylglycerin, Phenoxyethanol, Chlorphenesin, Sodium Hydroxide, Citric Acid, Coumarin.
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-Back - Targeted Body Acne SALICYLIC ACID WATER PROPANEDIOL GLYCERIN SALIX ALBA BARK NIACINAMIDE ROSEMARY GLYCYRRHIZA GLABRA LEMON PEEL CITRUS MAXIMA SEED ORANGE PEEL PANTHENOL TOCOPHEROL ALOE VERA LEAF PPG-1-PEG-9 LAURYL GLYCOL ETHER COCETH-7 POLYDEXTROSE POLYOXYL 40 HYDROGENATED CASTOR OIL ZINC PIDOLATE ETHYLHEXYLGLYCERIN PHENOXYETHANOL CHLORPHENESIN SODIUM HYDROXIDE CITRIC ACID MONOHYDRATE COUMARIN 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: 012
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