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| Product NDC Code | 82160-351 | ||||
|---|---|---|---|---|---|
| Drug Name | Delice |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| Labeler Name | Pella Pharmaceuticals Co. Ltd | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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.
Delice Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.Interactions Delice ® could react with certain hair care and hair tinting products.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Dimethicone (Blend) 92%
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.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.
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.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 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Composition Mineral Oil, Caprylic/ Capric Triglyceride and Lemon Fragrance.
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.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).
Purpose
Information about the drug product’s indications for use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Delice Dimethicone DIMETHICONE 100 DIMETHICONE 100 DIMETHICONE DIMETHICONE MINERAL OIL MEDIUM-CHAIN TRIGLYCERIDES FRAGRANCE LEMON ORC2001060
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.Secondary Package Secondary Package
Label Label
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.Lactation Delice ® should not be used in breast-feeding women because there is no enough studies demonstrate the safety use on these groups.
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.Precaution Keep out of reach of children
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Delice ® should not be used in pregnant women because there is no enough studies demonstrate the safety use on these groups.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.Presentation Glass bottle 50 ml, despensing pump and special comb.
Storage and handling
Information about safe storage and handling of the drug product.Storage Conditions Store below 30°C.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.Precautions Delice ® is for external use only. Avoid inhaling Delice ® . Precaution Keep out of reach of children
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 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.
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