DIMETICONE, 4%, cutaneous solution, 100-160ml bot.

STD SPAPDIME4S1

Valid Article

Former Code(s): DEXTDIME4S1
P03AX05
Anatomical Therapeutic Chemical Classification according to WHOCC
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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DIMETICONE solution

Definition

A non-sterile, liquid substance intended to be applied topically to the scalp and head hair to eradicate human head lice (Pediculus humanus capitis) through physical means. It contains synthetic compound agents (e.g., dimeticone, cyclomethicone, isopropyl myristate) that kill the lice through a non-poisonous action such as: 1) coating and encapsulating the lice preventing the excretion of water that will eventually smother them; or 2) coating them and causing them to dehydrate (loose water) and die; it may also penetrate the lice eggs in order to kill them. It does not include a lice comb. After application, this device cannot be reused.

Dimeticone is the preferred option for the treatment of head pediculosis except in children under 6 months of age.

Specifications

Solution for topical external use only

Dimeticone 4% lotion is a licenced medicinal product in the UK and a class I medical device in most other European countries.

Instructions for use

  • Apply sufficient lotion to cover dry hair from the base to the tip to ensure that no part of the scalp is left uncovered.
  • Work into the hair spreading the liquid evenly from roots to tips.
  • Allow hair to dry naturally for a minimum of 8 hours or overnight.
  • Wash out with normal shampoo, rinsing thoroughly with water.
  • Repeat the treatment after seven days.

Precautions for Use

Do not use in children under 6 months of age (use 1% permethrin lotion).

Avoid contact with the eyes.

Keep hair away from open flames and/or sources of ignition (including burning cigarettes) whilst being treated. Treated hair can readily burn if ignited.

Storage

Below 25ºC - Protect from sunlight