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| Product NDC Code | 69740-322 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Secura dimethicone protectant |
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| Type | Brand | ||||||
| Pharm Class | Skin Barrier Activity [PE] | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 259090 | ||||||
| Application Number | M016 | ||||||
| Labeler Name | Smith & Nephew Medical Ltd | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Dimethicone 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 Apply as needed Change wet and soiled diapers, garments, and linens promptly Cleanse the affected area and allow to dry Apply cream liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS water, petrolatum, isopropyl palmitate, propylene glycol, cetyl dimethicone copolyol, hexyl laurate, polyglycerol-4 isostearate, sodium chloride, paraffin, hydrogenated castor oil, beeswax, methylparaben, disodium EDTA, propylparaben
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 treat and prevent diaper dermatitis Protects minor skin irritation associated with diaper dermatitis and helps protect from wetness Temporarily protects and helps relieve chapped or cracked skin and lips
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.Secura Dimethicone Protectant DIMETHICONE HEXYL LAURATE ISOPROPYL PALMITATE METHYLPARABEN EDETATE DISODIUM PARAFFIN PETROLATUM PROPYLENE GLYCOL PROPYLPARABEN SODIUM CHLORIDE WATER YELLOW WAX DIMETHICONE DIMETHICONE HYDROGENATED CASTOR OIL POLYGLYCERYL-4 ISOSTEARATE
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 - PRINCIPAL DISPLAY PANEL- TUBE (3.5 g) Item #59435000 NDC 69740-322-01 Dimethicone Protectant Skin Protectant Contains 5% Dimethicone For treatment and prevention of incontinence-associated dermatitis Helps prevent and temporarily protect, chafed, chapped, cracked or windburned skin or lips Non-irritating, fragrance-free Pediatric tested CHG Compatible Does not clog briefs Smith & Nephew Secura ◊ Dimethicone Protectant Made in the USA for Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England Certain marks reg'd in U.S. Pat and Tm Off. PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - TUBE (114 g) Item #59432200 NDC 69740-322-00 Dimethicone Protectant Skin Protectant Contains 5% Dimethicone For treatment and prevention of incontinence-associated dermatitis Helps prevent and temporarily protect chafed, chapped, cracked, or windburned skin or lips Non-irritating, fragrance-free Pediatric tested CHG Compatible Does not clog briefs Smith & Nephew Secura ◊ Dimethicone Protectant Made in the USA for Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England. www.smith-nephew.com Trademark of Smith & Nephew. Certain marks reg'd U.S. Pat and Tm. Off. dimeth-3-5g imadimeth-114g
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
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 a Poison Control Center immediately
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTION OR COMMENTS? 1 800 876-1261
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 ask a doctor 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 do not get into 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
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