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| Product NDC Code | 80861-111 | ||||
|---|---|---|---|---|---|
| Drug Name | Spot on acne patch |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 1994404 | ||||
| Application Number | M006 | ||||
| Labeler Name | ACNEFREE, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 Cleanse and thoroughly dry your face. Remove patch adn apply directly onto the blemish. Leave patch on for at least 6 hours. Best used within 10 days after opening.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Acrylates Copolymer, Water, Denatured Alcohol , Vinyl Caprolactam/ VP/Dimethylaminoethyl Methacrylate Copolymer, Butylene Glycol, Epilobium Angustifolium Flower/Leaf/Stem Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Vitis Vinifera (Grape) Seed Extract, Volcanic Ash, Kaolin, PVP, Phenoxyethanol, Polysorbate 80, Sodium Hyaluronate, Sodium Metabisulfite, Phytosphingosine.
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 treatment of acne
Purpose
Information about the drug product’s indications for use.Purpose Spot on Acne Patch label
Spl product data elements
Usually a list of ingredients in a drug product.Spot On Acne Patch salicylic acid WATER TEA TREE OIL HYALURONIC ACID SALICYLIC ACID SALICYLIC ACID
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 Spot On Acne Patch label
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use Do not use if you are allergic to the patch or any of its components
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 Stop use and ask a doctor if skin irritation occurs.
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.For external use only Do not use Do not use if you are allergic to the patch or any of its components Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use Stop use and ask a doctor if skin irritation occurs.
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