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| Product NDC Code | 61354-099 | ||||
|---|---|---|---|---|---|
| Drug Name | Cream |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 422997 | ||||
| Application Number | M006 | ||||
| Labeler Name | Oxygen Development LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Salicylic Acid
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 Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer morning and night for best results. 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 Ingredient Water/Aqua, Propanediol, Glycerin, Caprylic/Capric Triglyceride, Dimethyl Isosorbide, Lactobacillus Ferment, Coconut Alkanes, Coco-Caprylate, Niacinamide, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Tranexamic Acid, Hexyl Laurate, Glycine Soja Soybean, C15-19 Alkane, Potassium Azeloyl Diglycinate, Hydrogenated Polydecene, Glyceryl Stearate, Ceramide NP, Ceramide AP, Bakuchiol, Fucus Spiralis Extract, Rhodomyrtus Tomentosa Fruit Extract, Tasmannia Lanceolata Fruit/Leaf Extract, Acetyl Glucosamine, Hydrolyzed Sodium Hyaluronate, Zinc Sulfate, Melia Azadirachta Leaf Extract, Centella Asiatica Leaf Extract, Silybum Marianum Seed Extract, Vitex Agnus - Castus Extra, Helianthus Annuus (Sunflower) Extract, Oryza Sativa (Rice) Bran Extract, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Allantoin, Panthenol, 1,2 - Hexanediol, Sodium Stearoyl Lactylate, Citric Acid, Xanthan Gum, Polyglyceryl - 3 Diisostearate, Polyacrylate Crosspolymer - 6, Coco - Caprylate/Caprate, Caprylhydroxamic Acid, Sodium Phytate, Tocopherol, Sodium Benzoate, Potassium Sorbate, Biosaccaharide Gum - 1, Phenoxyethanol, Sodium Anisate.
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 Treats Acne and helps skin heal. Penetrates pores to eliminate most acne blemishes and blackheads. Helps prevent new acne blemishes and blackheads from forming
Purpose
Information about the drug product’s indications for use.Purpose Acne Medication
Spl product data elements
Usually a list of ingredients in a drug product.cream Salicylic Acid NIACINAMIDE CETOSTEARYL ALCOHOL C15-19 ALKANE DIMETHYL ISOSORBIDE COCONUT ALKANES MEDIUM-CHAIN TRIGLYCERIDES COCO-CAPRYLATE LIMOSILACTOBACILLUS FERMENTUM TRANEXAMIC ACID BAKUCHIOL POTASSIUM AZELOYL DIGLYCINATE GLYCERIN DOCOSANOL SOYBEAN OIL 1,2-HEXANEDIOL SODIUM STEAROYL LACTYLATE HEXYL LAURATE SALICYLIC ACID SALICYLIC ACID GLYCERYL MONOSTEARATE HYDROGENATED POLYDECENE TYPE I CANDELILLA WAX WATER PROPANEDIOL
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.61354-099_aw
61354-099-01_aw
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.Other information Store at 20 - 25C (68-77F)
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 use only 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.
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
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