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| Product NDC Code | 61354-092 | ||||
|---|---|---|---|---|---|
| Drug Name | Mist |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1046487 | ||||
| Application Number | part333D | ||||
| Labeler Name | OXYGEN DEVELOPMENT, LLC | ||||
| 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 Ingredient Salicylic Acid.... 0.5%
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 Use once daily for treatment on clean, dry skin and before serums, moisturizers, and SPF. Recommended for PM use only. To use, mist evenly over your face, neck, and other affected areas.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water/Aqua, Sodium Benzoate, Sodium Polyacrylate, Caprylyl/Capryl Glucoside, Potassium Sorbate, Eucalyptus Globulus Leaf Oil, Glycerin, Salix Alba (Willow) Bark Extract, Rosa Damascena Flower Extract, Citric Acid, achillea Milefolium Flower Extract, Glucose, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil.
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 Use for treatment of acne
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.MIST SALICYLIC ACID LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE MELALEUCA ALTERNIFOLIA LEAF SALICYLIC ACID SALICYLIC ACID WATER SALIX ALBA BARK POTASSIUM SORBATE EUCALYPTUS GLOBULUS LEAF GLYCERIN CAPRYLYL/CAPRYL OLIGOGLUCOSIDE ROSA DAMASCENA FLOWER ACHILLEA MILLEFOLIUM FLOWER SODIUM BENZOATE SODIUM POLYACRYLATE (8000 MW)
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.Primary Package 61354-092_aw
Secondary Package 61354-092-01_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, seek medical help or contact Poison Control right away.
Keep out of reach of children If swallowed, seek medical help or contact Poison Control right away
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Contact with eyes Avoid contact with eyes
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 using more than one topical acne medication at a time. If irritation occurs, limit use to one topical acne medication at a time.
When using this product When using this product, skin irritation, and dryness is more likely to occur if using more than one topical acne medication at a time. If irritation occurs, limit use to one topical acne medication at a time.
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 Avoid contact with eyes Contact with eyes Avoid contact with eyes When using this product, skin irritation and dryness is more likely to occur if using more than one topical acne medication at a time. If irritation occurs, limit use to one topical acne medication at a time. Keep out of reach of children. If swallowed, seek medical help or contact Poison Control 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