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| Product NDC Code | 61354-091 | ||||
|---|---|---|---|---|---|
| Drug Name | Liquid |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 562600 | ||||
| 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 Shake well before use Start with damp skin Apply a small amount onto your fingertips and emulsify Gently cleanse the skin using circular motions Rinse with warm water and gently pat the skin dry Follow with your MONAT Skincare Routine
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water/Aqua, Sodium Cocoyl Glutamate, Sodium Cocoyl Isethionate, Propanediol, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Niacinamide, Cocamide MIPA, Glycerin, PEG-150 Distearate, Stearic Acid, Coconut Acid, Sodium PCA, Maclura Cochinchinensis Leaf Prenylflavonoids, Glycol Distearate, Laureth-4, PEG-120 Methyl Glucose Dioleate, Caprylyl/Capryl Glucoside, Polyglyceryl-10 Laurate, Polyglyceryl-10 Oleate, Sodium Chloride, SOdium Benzoate, Potassium Sorbate
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 For the treatment of acne Helps prevent new acne blemishes from forming
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.Liquid Salicylic acid SODIUM COCOYL GLUTAMATE PROPANEDIOL SODIUM C14-16 OLEFIN SULFONATE COCO MONOISOPROPANOLAMIDE SALICYLIC ACID SALICYLIC ACID COCAMIDOPROPYL BETAINE SODIUM COCOYL ISETHIONATE WATER PEG-120 METHYL GLUCOSE DIOLEATE SODIUM PYRROLIDONE CARBOXYLATE
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.Package Label 61354-091-01_AW 61354-091-01_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 product is swallowed, get medical help or contact a poison control center immediately
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 are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne treatment at a time. Avoid contact with eyes. If products occurs, rinse eyes 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
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