Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Reckitt Benckiser Healthcare (UK) Limited, 103-105 Bath Road, Slough, SL1 3UH, United Kingdom
Hypersensitivity to benzalkonium chloride or to any of the excipients listed in section 6.1.
Label Warning: For external use only.
Do not use around the eyes or ears or the genitalia, in the mouth or over large areas of the body that exceed 5% of the total body surface.
Do not inhale.
In the case of accidental eye contact, the eye should be irrigated with copious amounts of cold water.
This medicinal product contains 2080 mg propylene glycol in each 100 ml.
Propylene glycol may cause skin irritation.
The use of this spray with any other topical product is not recommended.
This medicine contains fragrance with d-limonene and lilial.
d-Limonene and lilial may cause allergic reactions.
Benzalkonium Chloride may be deactivated if used with soap or other surfactants.
The product is considered safe to use during pregnancy. Use during pregnancy is not expected to be associated with harmful effects as cutaneous absorption is minimal.
No effects on the breast fed newborn/infant are anticipated since the systemic exposure of the breast feeding woman to benzalkonium chloride is negligible.
In order to avoid possible ingestion by a breast fed child, application to the breast during lactation is not advised.
No known effects.
None known.
Post-marketing data indicates no specific adverse events of concern for this product.
Typical adverse events associated very rarely with topical antiseptics are given below, tabulated by system organ class and frequency.
Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| System Organ Class | Frequency | Adverse Event |
|---|---|---|
| Skin and Subcutaneous Tissue Disorders | Not known | Skin dystrophy, acrodermatitis, exacerbation of eczema, contact dermatitis, alopecia or rash. |
| General Disorders and Administration Site Disorders | Not known | Signs and symptoms of systemic allergic reactions including papular rash, pruritis or rash. Local site reactions including application site fissure, skin irritation, skin burning sensation, erythema, skin discolouration or skin exfoliation. |
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Benzalkonium chloride may be deactivated when used with soap or other surfactants.
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