Drug profile

The FDA adverse-event record for Purified Water Usp + Propylene Glycol + Malic Acid + Menthol/Citronella Fragrance + Benzoic Acid + Salicylic Acid + Simethicone

14 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Purified Water Usp + Propylene Glycol + Malic Acid + Menthol/Citronella Fragrance + Benzoic Acid + Salicylic Acid + Simethicone. See the species affected, top reactions, and outcomes below.

14
adverse-event reports
0.0%
death-coded share
Dog
most-reported species
9
Lack of efficacy - NOS - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
14
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Purified Water Usp + Propylene Glycol + Malic Acid + Menthol/Citronella Fragrance + Benzoic Acid + Salicylic Acid + Simethicone

Administration Routes

Auricular (Otic)Unknown

Species Affected

Dog 13
Cat 1

Most Affected Breeds

Retriever - Labrador 3
Bulldog - French 2
Retriever - Golden 2
Setter - Irish Red 1
Spaniel - Cocker American 1
Poodle (unspecified) 1
Spaniel - Springer (unspecified) 1
Terrier - Yorkshire 1
Bulldog 1
Siamese 1

Most Reported Reactions

Lack of efficacy - NOS 9
CULTURE/TITER DATA ABNORMAL 4
Vomiting 2
Ear discharge 1
Behavioural disorder NOS 1
Underdose 1
Hearing decreased 1
Application site pain 1
Other ear disorder NOS 1
Aural haematoma 1
INEFFECTIVE, EAR MITES 1

Outcome Breakdown

Outcome Unknown
8 (57.1%)
Ongoing
5 (35.7%)
Recovered/Normal
1 (7.1%)

Purified Water Usp + Propylene Glycol + Malic Acid + Menthol/Citronella Fragrance + Benzoic Acid + Salicylic Acid + Simethicone Adverse Event Insights

14 reports name Purified Water Usp + Propylene Glycol + Malic Acid + Menthol/Citronella Fragrance + Benzoic Acid + Salicylic Acid + Simethicone; 0 recorded a death outcome (0.0% of reported events, not a population-level mortality rate). Active ingredient: Purified Water Usp + Propylene Glycol + Malic Acid + Menthol/Citronella Fragrance + Benzoic Acid + Salicylic Acid + Simethicone. Administration routes: Auricular (Otic), Unknown.

By species: Dog (13 reports), Cat (1 reports). By breed: Retriever - Labrador (3), Bulldog - French (2), Retriever - Golden (2).

Leading clinical signs: Lack of efficacy - NOS (9), CULTURE/TITER DATA ABNORMAL (4), Vomiting (2), Ear discharge (1). Outcome, 14 coded reports: Outcome Unknown leads at 57.1%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.