CHLORHEXIDIN

CHLORHEXIDINE Powder

Product properties

Chlorhexidine Powder
Medical device for the care and protection of skin areas at risk of infection and for the care of the navel of newborns

1. Intended use
Chlorhexidine Powder is used for the care and protection of intact skin areas at risk of infection and wound edge areas. The product binds and regulates skin moisture. The development of good germ growth conditions is effectively prevented. The use of Chlorhexidine Powder thus prevents regional skin infections (e.g. intertrigo), accompanied by itching, burning and pain of the skin.

2. Areas of application
Chlorhexidine Powder is ready to use for the cleansing care and protection of the intact (healed) navel area of newborns, skin areas at risk of infection such as the armpit, skin folds caused by obesity (e.g. chest, abdomen, groin) as well as the genital and anal area. The product is suitable for the professional care of the sick, disabled and elderly as well as for domestic use.

3. Side effects
Occasionally, hypersensitivity reactions of the skin (e.g. contact dermatitis, photosensitization) and rarely also anaphylactic reactions may occur.

4. Tissue compatibility
The skin compatibility of the product is good in a concentration of 1% in water, even with repeated use. In adults, no absorption was detected after repeated application of Chlorhexidine Powder to healthy skin.

5. Contraindications
Chlorhexidine Powder must not be used on poorly perfused tissue, on the eardrum, on the eye or in the eye area, in the case of allergies (especially in the case of a previous hypersensitivity reaction to chlorhexidine), on skin wounds or ulcerations.

Caution

During pregnancy or lactation, no large-scale application should be made.

6. General safety instructions
The product is intended exclusively for external use on intact skin and must not enter the body through ingestion, injection or infusion.

Countermeasures in case of accidental ingestion

The ingredient chlorhexidine is inactivated by sucrose and can be deactivated by polysorbate-80, insoluble magnesium, zinc and calcium salts.

Caution

Keep out of reach of children. Store safely! When used on intact skin in wound edge areas, direct contact of the product with the wound must be avoided. When using Chlorhexidine Powder in the genital or anal area, the excipients Vaseline and paraffin can reduce the tear resistance of condoms made of latex and thus impair the safety of condoms. When handling powders containing talc, excessive dusting and inhalation of the dust should be avoided as far as possible.

Caution

Chlorhexidine Powder should not be used in case of hypersensitivity to the ingredients. Use with caution in newborns and especially in premature babies. Chlorhexidine Powder can cause chemical burns to the skin.

7. Product properties
Chlorhexidine Powder cleanses through its physical properties and binds or regulates skin moisture in skin areas at risk of infection. The special powder base of the product with a particle size of less than 250 /um enables a high moisture absorption capacity of the powder through adsorption of the liquid to the particle surface. The drying properties of the particles, together with the good sliding ability, contribute to a reduction of friction on body surfaces. Due to its preservative ingredients, Chlorhexidine Powder is effective at a neutral and slightly alkaline pH value.

8. Product application
The affected skin areas are evenly dusted with Chlorhexidine Powder by the user (patient or caregiver) several times a day. Continuous use should not exceed a period of 4 weeks. Used containers and outer cartons should be disposed of via household waste, preferably separately. Expired or used containers should be disposed of via the pharmacy.

9. Physical product data

Composition

Chlorhexidine Powder contains: Adipic acid, talc, zinc oxide, precipitated silicon dioxide, liquid paraffin, white Vaseline, wool wax, 1% chlorhexidine digluconate (equivalent to 0.5% chlorhexidine) as a preservative.

Appearance, smell

Almost white powder with a slightly perceptible smell.

Shelf life

2 years.

Storage conditions

Chlorhexidine Powder should be stored dry at room temperature (in the range of 15-25°C). Close the powder can tightly after use.

10. Delivery specification
15 g powder can, packed in a folding box 50 g powder can, packed in a folding box.

11. Manufacturer/Distributor

Manufacturer and distributor of the medical device

Carinopharm GmbH
Bahnhofstr. 18
31008 Elze
Telephone: 0180 2 1234-01*
Telefax: 0180 2 1234-02*
E-Mail: info@carinopharm.de
*0.06 EUR per call from the German landline network; maximum mobile price: 0.42 EUR per minute

This information for use was last revised in May 2015.

Source: Information from the package insert
Status: 04/2018