DELICE- dimethicone solution

Delice by

Drug Labeling and Warnings

Delice by is a Homeopathic medication manufactured, distributed, or labeled by Pella Pharmaceuticals Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Dimethicone (Blend) 92%

Composition

Mineral Oil, Caprylic/ Capric Triglyceride and Lemon Fragrance.

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.

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).

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.

Precautions

Delice ® is for external use only.

Avoid inhaling Delice ®.

Precaution

Keep out of reach of children

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.

Pregnancy

Delice ® should not be used in pregnant women because there is no enough studies demonstrate the safety use on these groups.

Lactation

Delice ® should not be used in breast-feeding women because there is no enough studies demonstrate the safety use on these groups.

Interactions

Delice ® could react with certain hair care and hair tinting products.

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.

Storage Conditions

Store below 30°C.

Presentation

Glass bottle 50 ml, despensing pump and special comb.

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.

Secondary Package

Label

INGREDIENTS AND APPEARANCE

DELICE 
dimethicone solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82160-351
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE 100 (UNII: RO266O364U) (DIMETHICONE 100 - UNII:RO266O364U)	DIMETHICONE 100	25 g  in 50 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	21 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82160-351-01	1 in 1 CARTON	09/19/2011
1		50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/19/2011

Labeler - Pella Pharmaceuticals Co. Ltd (562370925)