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| Product NDC Code | 64760-735 | ||||
|---|---|---|---|---|---|
| Drug Name | Glytone acne back and chest treatment |
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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 | Pierre Fabre USA Inc. | ||||
| 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 Ingredients 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 Spray directly onto cleansed affected areas of the back, shoulders and chest by holding 3 to 6 inches away from the skin one to three times daily. Pump works upside down and for optimal application. Let dry prior to putting on clothes. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients AQUA (WATER), ALCOHOL DENAT., METHYLPROPANEDIOL, GLUCONOLACTONE, POLYSORBATE 20, POTASSIUM SORBATE, SODIUM GLUCONATE, SODIUM BENZOATE, CITRIC ACID, GLYCERIN, HIBISCUS SARBARIFFA FLOWER EXTRACT, CENTELLA ASIATICA (GOTU KOLA) LEAF EXTRACT, CAMELLIA SINENSIS (WHITE TEA) LEAF EXTRACT, CAMELLIA OLEIFERA (GREEN TEA) LEAF EXTRACT, ALOE BARBADENSIS LEAF JUICE POWDER, SODIUM HYDROXIDE
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. Dries and clears acne blemishes and allows skin to heal. Penetrates pores to eliminate most acne blemishes, blackheads, and whiteheads. Helps prevent the development of new acne blemishes, blackheads, and whiteheads.
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.Glytone Acne Back and Chest Treatment Salicylic acid SALICYLIC ACID SALICYLIC ACID HIBISCUS SABDARIFFA FLOWER POTASSIUM SORBATE ALOE VERA LEAF GLYCERIN ANHYDROUS CITRIC ACID CENTELLA ASIATICA GREEN TEA LEAF SODIUM HYDROXIDE CALCIUM GLUCONATE PHENOXYETHANOL WATER POLYSORBATE 20 SODIUM GLUCONATE GLUCONOLACTONE ALCOHOL SODIUM BENZOATE METHYLPROPANEDIOL Glytone Acne Treatment Salicylic acid WATER ISOPROPYL ALCOHOL BENZALKONIUM CHLORIDE POLYSORBATE 20 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.GLYTONE Acne Back & Chest Treatment Spray ACNE THERAPY 2% Salicylic Acid Acne Medication Gluconolactone (PHA) Aloe 240 mL / 8.0 FL. OZ. label
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
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.
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 rash occurs.
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 use only one topical acne medication at a time. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water. Spray in a well ventilated area. Do not inhale.
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 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 use only one topical acne medication at a time. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water. Spray in a well ventilated area. Do not inhale. Stop use and ask a doctor if rash occurs. 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