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| Product NDC Code | 52000-417 | ||||
|---|---|---|---|---|---|
| Drug Name | Dimethicone 1 skin protectant |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 199680 | ||||
| Application Number | M016 | ||||
| Labeler Name | Universal Distribution Center LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Dimethicone 1%
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 Apply as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients water, cetearyl alcohol, mineral oil, glycerin, petrolatum, ceteareth-20, propylene glycol, cetrimonium chloride, carbomer, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydoxide, avena sativa (oat) kernel flour, tocopheryl acetate, FD&C yellow no.6, FD&C yellow no.5, FD&C blue no.1
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 • Helps prevent and temporarily protects chafed, chapped or cracked skin. • Helps prevent and protect from the drying effects of wind and cold weather.
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.Dimethicone 1 Skin Protectant Dimethicone DIMETHICONE DIMETHICONE WATER CETOSTEARYL ALCOHOL MINERAL OIL GLYCERIN PETROLATUM POLYOXYL 20 CETOSTEARYL ETHER PROPYLENE GLYCOL CETRIMONIUM CHLORIDE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE BENZYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE SODIUM HYDROXIDE OATMEAL .ALPHA.-TOCOPHEROL ACETATE FD&C YELLOW NO. 6 FD&C YELLOW NO. 5 FD&C BLUE NO. 1
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.Packaging SkinProtectant-417
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
with natural colloidal oatmeal protects and relieves dry skin fragrance free long lasting moisturizer *Compare to Aveeno ® U Daily Moisturizing Lotion helps prevent and protect dry skin, providing temporary relief of chapping associated with dry skin. This naturally nourishing, non-greasy formula absorbs quickly, won't clog pores, and contains no added fragrance. U Daily Moisturizing Lotion leaves your skin soft, smooth and naturally healthy looking. Distributed by: Universal Distribution Center 96 Distribution Boulevard Edison, NJ 08817
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 Immediately.
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 • Do not get into eyes. Stop use and ask a doctor if • Conditions worsens. • Symptoms last more than 7 days or clear up and occur again within a few days. Do not use on • Deep or puncture wounds • Animal bites • Serious burns. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center Immediately.
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