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Product NDC Code | 64760-733 | ||||||
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Drug Name | Glytone acne clearing toner |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | LIQUID | ||||||
Application Number | M006 | ||||||
Labeler Name | Pierre Fabre USA Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient 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 After cleansing, apply toner to a cotton pad and gently apply over affected area one to three times daily. Do not rinse. 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. 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), DEXTRIN, POLYDEXTROSE, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, POLYSORBATE 20, PROPANEDIOL, AMYLOPECTIN, NIACINAMIDE, GLYCERIN, EPILOBIUM FLEISCHERI EXTRACT, CITRIC ACID, POTASSIUM SORBATE, ALLANTOIN, MANDELIC ACID, SALIX ALBA (WILLOW) BARK EXTRACT, SERENOA SERRULATA FRUIT EXTRACT, ALOE BARBADENSIS LEAF JUICE, PYRUS MALUS (APPLE) FRUIT EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) BARK/LEAF/TWIG EXTRACT, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, SODIUM BENZOATE, 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, black-heads 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 Clearing Toner Salicylic Acid POLYDEXTROSE WHEY PROTEIN HYDROLYSATE SODIUM BENZOATE GLYCERIN EPILOBIUM FLEISCHERI WHOLE ALLANTOIN MANDELIC ACID SAW PALMETTO SALIX ALBA BARK ALOE VERA LEAF CALENDULA OFFICINALIS FLOWER APPLE GLYCYRRHIZA GLABRA AMYLOPECTIN, UNSPECIFIED SOURCE NIACINAMIDE 1,2-HEXANEDIOL CAPRYLYL GLYCOL PROPANEDIOL HAMAMELIS VIRGINIANA LEAF SALICYLIC ACID SALICYLIC ACID ANHYDROUS CITRIC ACID SODIUM HYDROXIDE POTASSIUM SORBATE WATER ICODEXTRIN POLYSORBATE 20
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 - 200 mL GLYTONE Acne Clearing Toner Acne Therapy 2% Salicylic Acid Acne Medication Niacinamide 200 mL / 6.76 FL. OZ. acne clearing toner
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, only use one topical acne medication at a time. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
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. 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. 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.
Flammable: Keep away from fire or flame
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