Delice
Dimethicone
Pella Pharmaceuticals Co. Ltd
Human Otc Drug
NDC 82160-351Delice also known as Dimethicone is a human otc drug labeled by 'Pella Pharmaceuticals Co. Ltd'. National Drug Code (NDC) number for Delice is 82160-351. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Delice drug includes Dimethicone - 21 g/50mL Dimethicone 100 - 25 g/50mL . The currest status of Delice drug is Active.
Drug Information:
| Drug NDC: | 82160-351 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Delice |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Dimethicone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pella Pharmaceuticals Co. Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DIMETHICONE - 21 g/50mL
DIMETHICONE 100 - 25 g/50mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 19 Sep, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Pella Pharmaceuticals Co. Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 6253344200351
|
| UPC stands for Universal Product Code. |
| NUI: | N0000010282
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 92RU3N3Y1O
RO266O364U
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class PE: | Skin Barrier Activity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Skin Barrier Activity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 82160-351-01 | 1 BOTTLE, GLASS in 1 CARTON (82160-351-01) / 50 mL in 1 BOTTLE, GLASS | 19 Sep, 2011 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Characteristics delice ® does not contain any harmful insecticides.the solutioncreeps deeply into the breathing syatem of lice, nymphs and eggs (nits) resultingin suffocation. because this mechanism of action is physical, the development of resistance inlice is not possible.
Product Elements:
Delice dimethicone dimethicone 100 dimethicone 100 dimethicone dimethicone mineral oil medium-chain triglycerides fragrance lemon orc2001060
Drug Interactions:
Interactions delice ® could react with certain hair care and hair tinting products.
Indications and Usage:
Indications delice ® is a physical treatment of scalp hair in case of infestation with head lice; if used as instructedit is also effective against nymphs and eggs (nits).
Warnings:
Warnings when using delice®, you should make sure that the solution does not come into contact with eyes or mucous membranes (nose and throat). if the solution gets into the eyes accidently, rinse for 10 - 15 minutes with plenty of water. if irritation persists please consult your doctor or pharmacist. because some ingredients are flammable, delice® must not be used near naked flames or heat sources, including hair dryers. keep delice® away from sources of ignition and do not smoke during using this product. if delice® spilled accidently, there is danger of slipping. spillage should therefore be cleaned up immediately.
Dosage and Administration:
Instructions before delice ® is used for the first time; the enclosed dispensing pump must be screwed onto the glass bottle. to do this, remove the screw cap from the bottle and screw the dispensing pumpon tight. always hold the spray bottle upright or the pump will not be able to work properly. please note that the pump will need to primed, by pumping, when used for the first time and when used it has been unused for a long period. inspect all scalp hair of each family member with the delice ® comb. all affected family members must use delice ® on the same day to avoid re-infestation. delice ® comb should be cleaned thoroughly after use. 1. spray delice ® on the hair and leave it for 30 minutes. use delice on a dry hair; spray the product on overall the hair with scalp massaging by using the inserted comb, to work effectively, whole hair should be wetted by delice completely, so the product reaches all the lice, egges and nits. the amount of used product depends on the
Read more...hair length and density. make sure that the hair near the scalp and behind the ears is covered by the product because the lice and nits are concentrated there. leave delice on hair for 30 minutes. 2. after 30 minutes, comb the hair carefully using the lice comb. after leaving delice on hair for 30 minutes minimum, comb the hair by using the inserted comb to remove the strangled lice, delice solution makes the hair combing easier, because it contains ingredients which make the combing hair regardless its length easier. what is the right way to use the lice comb? divide the hair into several parts, and each part in several smaller strands of hair, comb each strand separately with the hair roots and ending with spikes, attach each combed strand backwards, and clean the comb after each strand combing with tissues before resuming combing the other strands. 3. do not wash out leave the hair to dry at least 8 hours (overnights). lice eggs are more flexible and difficult to remove it, lice makes lice eggs adhere with hair like small balls with white heads, in addition it secretes an adhesive material similar to the composition of hair, even good combing is not enough to remove all the eggs, so you should leave delice on hair for 8 hours, even the most stubborn eggs will choke. 4. wash out with normal commercial shampoo. you can wash delice solution from hair after eight hours by using any normal shampoo, any traces of solution remains on the hair after the first washing can be easily removed by a second washing. 5. after 8-10 days, re-apply if necessary. to ensure that all lice and eggs are treated, you must re-apply using the solution by the same procedure which described above. delice use is safe and you can reuse it many times if necessary.
Contraindications:
Contraindications delice ® must not be used in people with known hypersensitivity to any of its ingredients. if any allergic skin reactions should occur, treatment should be stopped immediately. delice ® should not be used in children under the age of two years because thee s no enoughstudies demonstrate the safety use on this group.
Adverse Reactions:
Side effects in rare cases, allergic skin reactions can be triggered by one of the ingredientsof delice ® . these occur as inflammation, sewlling, redeness or rashes.
Drug Interactions:
Interactions delice ® could react with certain hair care and hair tinting products.
Use in Pregnancy:
Pregnancy delice ® should not be used in pregnant women because there is no enough studies demonstrate the safety use on these groups.
How Supplied:
Presentation glass bottle 50 ml, despensing pump and special comb.
Package Label Principal Display Panel:
Secondary package secondary package
Label label