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| Product NDC Code | 63517-126 | ||||
|---|---|---|---|---|---|
| Drug Name | Personal cleansing with dimethicone |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CLOTH | ||||
| RxCUI drug identifier | 1039149 | ||||
| Application Number | M022 | ||||
| Labeler Name | Cardinal Health 200, Inc | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Dimethicone 3.2% Purpose Skin Protectant
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 Pull back label and remove wipes Thoroughly cleanse soiled area, using one wipe at a time Use as often as necessary Dispose of cloths in a waste receptacle Do not flush Wipes may be used at room temperature but if heating is desired, wipes may be warmed in a wipes warmer. Wipes should be warmed: In a single warming session at temperatures not exceeding 52°C (125°F) and for a maximum of 200 hours. Discard wipes that have been: Exposed to warming temperatures exceeding 52°C (125°F); or Stored longer than 200 hours within the warmer; or Been warmed, allowed to cool, and then re-warmed Warming Instructions:
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aqua, Glycerin, PPG-15 Stearyl Ether, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Cetearyl Alcohol, Xanthan Gum
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 temporarily protects and helps relieve chapped or cracked skin helps prevent perineal dermatitis protects minor skin irritation associated with perineal dermatitis
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Personal Cleansing with Dimethicone DIMETHICONE WATER GLYCERIN PPG-15 STEARYL ETHER GLYCERYL MONOSTEARATE PEG-100 STEARATE PHENOXYETHANOL ALOE VERA LEAF CAPRYLYL GLYCOL CETOSTEARYL ALCOHOL XANTHAN GUM DIMETHICONE DIMETHICONE
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 Labeling: Product Label French Translation for Drug Facts Panel Drug Facts Panel
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other Information When not in a warmer, store between 15-30˚C (59-86˚F).
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 On deep or puncture wounds Animal bites Serious burns
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 Posion Control Center right away. Discontinue if irritation or redness develops Gloves diminish sensitivity to heat Closely monitor heat level with infants, unresponsive or skin sensitive individuals
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 and contact a physician if condition worsens symptoms last more than 7 days or clear up and occur again within a few days.
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 Avoid direct contact with the eyes
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 Avoid direct contact with the eyes Stop use and contact a physician if condition worsens symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact Posion Control Center right away. Discontinue if irritation or redness develops Gloves diminish sensitivity to heat Closely monitor heat level with infants, unresponsive or skin sensitive individuals Do not use On deep or puncture wounds Animal bites Serious burns
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