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Product NDC Code | 10742-8177 | ||||
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Drug Name | Oxy overnight acne reducing patches |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | PATCH | ||||
RxCUI drug identifier | 1994404 | ||||
Application Number | part333D | ||||
Labeler Name | The Mentholatum Company | ||||
Packages |
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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 cleanse skin thoroughly before applying this product apply patch(es) to affected area(s) to remove, gently peel back patch and discard because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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.Inactive ingredients acrylates/ethylhexyl acrylate copolymer, water, nonoxynol-30, alcohol denatured, butylene glycol, C13-14 isoparaffin, epilobium angustifolium flower/leaf/stem extract, kaolin, laureth-7, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol, phytosphingosine, polysorbate 80, PVP, sodium hyaluronate, sodium hydroxide, sodium metabisulfite, sodium polyacrylate, vitis vinifera (grape) seed extract, volcanic ash
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 and helps prevent acne
Purpose
Information about the drug product’s indications for use.Purpose Salicylic acid - Acne treatment
Spl product data elements
Usually a list of ingredients in a drug product.OXY Overnight Acne Reducing Patches salicylic acid 2-ETHYLHEXYL ACRYLATE WATER NONOXYNOL-30 ALCOHOL BUTYLENE GLYCOL C13-14 ISOPARAFFIN EPILOBIUM ANGUSTIFOLIUM WHOLE KAOLIN LAURETH-7 TEA TREE OIL PHENOXYETHANOL PHYTOSPHINGOSINE POLYSORBATE 80 POVIDONE, UNSPECIFIED HYALURONATE SODIUM SODIUM HYDROXIDE SODIUM METABISULFITE SODIUM POLYACRYLATE (8000 MW) VITIS VINIFERA SEED 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.Principal Display Panel Oxy Overnight Acne Reducing Patches
Principal Display Panel Drug Facts
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-877-636-2677 MON-FRI 9 AM - 5 PM (EST)
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 keep away from eyes, lips and mouth. If contact occurs, flush thoroughly with water. 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. If pregnant or breast-feeding ask a health professional before use.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use.
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 keep away from eyes, lips and mouth. If contact occurs, flush thoroughly with water. 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. If pregnant or breast-feeding ask a health professional before use. 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