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| Product NDC Code | 64760-719 | ||||
|---|---|---|---|---|---|
| Drug Name | Glytone acne self-foaming cleanser |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 865105 | ||||
| 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 Purpose Salicylic Acid 0.5% 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 At initial use, turn pump head counter-clockwise to unlock. Dispense a small amount into your hand and mix with a little water. Apply a thin layer over entire affected area in a circular motion and rinse thoroughly with warm water two times daily. For a mask-like effect, leave on for 30 seconds before rinsing. Because of excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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.Water, Methyl Perfluoroisobutyl Ether, Butylene Glycol, Sorbitol, Methyl Perfluorobutyl Ether, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Chondrus Crispus (Carrageenan), Cyclopentasiloxane, Cyclohexasilioxane, Sodium Cocamidopropyl PG-Dimonium Chloride Phosphate, Polyhydroxystearic acid, Isononyl Isononanoate, Ethylhexyl Isononanoate, Xanthan Gum, Sodium Hydroxide, Perfluorohexane, o-Cymen-5-ol, Tetrasodium EDTA, Cinnamomum Zeylanicum Bark Extract, Oryza Sativa (Rice) Bran Extract, Yeast Polysaccharides, Blue 1 (CI 42090)
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.Acne treatment
Spl product data elements
Usually a list of ingredients in a drug product.Glytone Acne Self-Foaming Cleanser salicylic acid .BETA.-ELEOSTEARIC ACID ORYZA SATIVA WHOLE CITRUS FRUIT 1-CHLORO-2-METHYL-1-PROPENE LIMONENE DIEPOXIDE 2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL SODIUM HYDROXYPROPYLSULFONATE LAURYLGLUCOSIDE-7 CROSSPOLYMER 1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) ISOSTEARAMIDOPROPYL ETHYLDIMONIUM ETHOSULFATE ISOEICOSANE ETHYLHEXYLGLYCERIN DICLOFENAC SODIUM ACRYLATES CROSSPOLYMER-6 POLYGLUCOSE SORBITOL CARBOXYMETHYL ETHER CARBAZOCHROME SODIUM SULFONATE HYDRATE BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES POLYHYDROXYSTEARIC ACID (2300 MW) WATER SODIUM LAURETH SULFATE CARRAGEENAN COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE ISONONYL ISONONANOATE PHENOXYETHANOL XANTHAN GUM FD&C BLUE NO. 1 SALICYLIC ACID SALICYLIC ACID COCOS NUCIFERA WHOLE OLEA EUROPAEA FLOWER ETHYL PERFLUOROISOBUTYL ETHER DIMETHICONE PEG-8 ADIPATE CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES ACETYL ARGININE ETHYL PERFLUOROBUTYL ETHER GLYCERIN SODIUM CHLORIDE SODIUM HYDROXIDE ISOHEXADECANE 1,3-BUTYLENE GLYCOL 1-PROPIONATE MALTOOLIGOSYL GLUCOSIDE INDOL-3-YL SODIUM PHOSPHATE CENTELLA ASIATICA LAMINARIA DIGITATA HYDROLYZED ALGINIC ACID DISODIUM LAUROYL GLUTAMATE CETEARYL METHICONE (15000 MW) PEG-120 GLYCERYL STEARATE POTASSIUM CHLORIDE DIBASIC POTASSIUM PHOSPHATE HYDROGENATED STARCH HYDROLYSATE DISODIUM ASCORBYL SITOSTANOL PHOSPHATE
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 Self-Foaming Cleanser 0.5 salicylic acid non-irritating formula 180 ml/6.1 fl oz Acne Self Foaming Cleanser
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. 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.
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