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Product NDC Code | 84262-012 | ||||
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Drug Name | Acne back chest treatment |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | AEROSOL, SPRAY | ||||
Application Number | M006 | ||||
Labeler Name | GLYTONE LLC | ||||
Packages |
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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 for optimal application. Let dry prior to putting on clothes. Beacuase 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. 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 AQUA (WATER), ALCOHOL DENAT., METHYLPROPANEDIOL, GLUCONOLACTONE, POLYSORBATE 20, POTASSIUM SORBATE, SODIUM GLUCONATE, SODIUM BENZOATE, CITRIC ACID, GLYCERIN, HIBISCUS SABDARIFFA FLOWER EXTRACT, CENTELLA ASIATICA (GOTU KOLA) LEAF EXTRACT, CAMELLA SINENSIS (WHITE TEA) LEAF EXTRACT, CAMELLA OLEFERA (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.Acne Back Chest Treatment Salicylic Acid GLYCERIN SODIUM BENZOATE CENTELLA ASIATICA LEAF HIBISCUS SABDARIFFA FLOWER SALICYLIC ACID SALICYLIC ACID POTASSIUM SORBATE GLUCONOLACTONE POLYSORBATE 20 SODIUM HYDROXIDE CITRIC ACID MONOHYDRATE CALCIUM GLUCONATE WATER WHITE TEA ALCOHOL METHYLPROPANEDIOL SODIUM GLUCONATE CAMELLIA SINENSIS SEED OIL
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. acne
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Flammable Keep away from fire or flame.
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.Drug Facts
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 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 For external use only. 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 for optimal application. Let dry prior to putting on clothes. Beacuase 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. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Flammable Keep away from fire or flame. 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 eye contact occurs, rinse thoroughly with water. spray in a well ventilated area. Do not inhale. 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