CHLORHEXIDINE GLUCONATE 2% W/V with 4% v/v Isopropyl Alcohol (IPA)
THERAPEUTIC CLASSIFICATION Antibacterial skin cleanser
ACTION AND CLINICAL PHARMACOLOGY Chlorhexidine is a bactericidal antiseptic effective against a large range of vegetative gram positive and gram negative bacteria, although more effective against gram positive bacteria. Some species of Pseudomonas and Proteus are relatively less susceptible. Chlorhexidine is ineffective against acid-fast bacteria, bacterial spores, fungi and viruses.
As a cationic material, chlorhexidine is incompatible with soaps and other anionic materials.
At a concentration of 2% chlorhexidine is incompatible with borates, bicarbonates, carbonates, chlorides, citrates, phosphates and sulfates, forming salts of low solubility which may precipitate from solutions after standing.
Chlorhexidine is most active at a neutral pH; its activity is reduced by organic matter (blood, serum, etc.) and by phospholipids.
INDICATIONS AND CLINICAL USE STANHEXIDINE 2% is a low sudsing antibacterial skin cleanser
The solution is ready for use; do not dilute.
CONTRAINDICATIONS Patients who have previously experienced a hypersensitivity to chlorhexidine (such reactions are extremely rare)
WARNINGS For external use only. Keep out of the eyes and avoid contact with brain, meninges or middle ear. If eyes are accidentally splashed, they should be promptly and thoroughly rinsed with water. Prolonged contact may cause eye damage. Do not use in body cavities. Do not inject. If accidental contact is suspected, wash thoroughly with sterile water before starting surgical procedure.
Keep away from children.
If swallowed accidentally, induce vomiting immediately. Administer milk, egg white or mild soap. Contact a physician.
PRECAUTIONS Fabrics which have been in contact with chlorhexidine may develop a brown stain if bleached with a hypochlorite. Perborate bleach may be used instead.
ADVERSE REACTIONS Skin irritation may occasionally occur. Generalized allergic reactions to chlorhexidine have been reported, but are extremely rare.
TREATMENT OF OVERDOSAGE Chlorhexidine taken orally is poorly absorbed. If swallowed accidentally, induce vomiting immediately. Administer milk, egg white or mild soap. Contact a physician.
Blood transfusions may be necessary to counteract haemolysis.
DIRECTIONS FOR USE Wet skin thoroughly with water. Apply a small amount of STANHEXIDINE® 2% with 4% IPA, work up suds and wash. Rinse with water. FOR EXTERNAL USE ONLY.
PHARMACEUTICAL INFORMATION RAW MATERIAL Proper name: Chlorhexidine gluconate solution. Chemical name: 1,1′-hexamethylene bis-[5-(4-chlorophenyl) biguanide] digluconate Chemical formula: C22H30Cl2N10 • 2 C6H12O7 Molecular weight: 897.8 Physical form: Almost colorless, clear or not more than slightly opalescent liquid, odorless. Solubility: Miscible with water, with not more than 5 parts of 96% ethyl alcohol and with not more of 5 parts of acetone.
STABILITY AND STORAGE RECOMMENDATIONS Store at a temperature between 4 and 25°C in tightly closed containers and protect from light. The solution remains stable for 30 days after the bottle has been opened.
STANHEXIDINE 2% is a red-orange solution available in plastic bottles of 450 mL (Product Code: L0000012) and 4 L (Product code: L0000013).
STANHEXIDINE 2% contains 2% Chlorhexidine Gluconate (w/v), 4% (v/v) Isopropyl Alcohol as a preservative, FD&C n°40, Polyethylene Glycol-150 Distearate, Nonyl Phenol Ethamoxide, Glycerine, Polyoxyethylene (80) Sorbitan Monolaurate in Purified Water.
Does not contain any paraben, sulfite or tartrazine.
Omega Laboratories Limited Montréal, Canada H3M 3E4