A popular children's nappy rash cream is being recalled, amid complaints from parents that the product caused burns and the company downplayed reactions.
The Therapeutic Goods Administration (TGA) has advised parents not to use two batches of Curash Nappy Rash Cream.
The batch numbers are 1118263 and 1116727 and have been in circulation since last year.
The TGA statement was issued weeks after Curash announced the product recall on its website, stating there had been reports of increased skin sensitivity, redness and rash.
The company said symptoms subsided after the affected skin was washed with water, however some parents argued the reaction was much worse than what had been described.
Parents angered by response
Curash has been used by families for years without issue, and parents have questioned what changed in the batches that have been recalled.
Mother of two, Jacqui, contacted the company in early February after both her children had reacted to the cream.
She said she was disappointed that she only got a response from the company when she followed up a second time.
"Curash's customer service has been extremely poor. They were not forthcoming with the ingredients or the change in formulation," she said.
She described Curash's suggestion that there had been reports of redness or a rash as "incorrect, deceptive and misleading".
"They need to update the recall and investigate the cause of the reactions," she said.
"Symptoms did not subside after the affected skin was washed, as the skin had been burnt by the cream.
"Both my children experienced significant pain as a result of using Curash and at less than three weeks of age my baby screamed every time she toileted and had cream applied.
"It was incredibly distressing."
She, like other mothers, pushed to find out what changes had been made to the cream.
Curash said that there had been a "change to the preservative system and the removal of almond oil".
A number of ingredients were removed, including almond oil, propylene glycol, methylparaben and propylparaben and fragrance ingredients.
Curash said that citric acid, phenoxyethanol, cetyl alcohol, stearyl alcohol, ceteareth-20 and 2,4-dichlorobenzyl were added.
Rash burned adults as well
Other parents also expressed their disappointment in the company not taking their concerns seriously.
"Appalled by the amount of complaints and reviews and how long it took for a recall," one mother said on Curash's Facebook page.
One mother explained how she tried the cream on herself and reacted soon after.
"I used this on myself the other day. It burned I had to wash it off and use baby powder to stop the burning," she said.
"Our baby was hospitalised at four weeks old from what we now know were the burns cause by this nappy rash cream … we are horrified it took this long to be identified as a problem and be recalled," another mother said.
"She [my baby] has had these horrible pustules on her perineal area for 14 days now … she was put on antibiotics for it after trying an antifungal cream that did nothing. Only after four days of using the antibiotics and stopping the Curash cream yesterday in efforts to rule anything and everything out that could be causing it has it just started to clear up," someone else posted.
"My son has suffered with large painful welts for months that have been resistant to multiple prescribed topical ointments from our GP," added a mother.
Cream underwent testing, Curash says
The ABC asked Curash when it first received a complaint about the cream, how many parents have contacted the company raising concerns and what if any ingredients had been removed since the reactions were reported.
Curash did not answer the ABC's questions but encouraged customers to get in touch via their help line or website so the company could obtain further information that "assists in addressing the situation".
"We can assure all Australian consumers that, prior to launch, the Curash Nappy Rash Cream underwent the same rigorous clinical safety assessment procedures as all of our products," the statement said.
"We are continuing to investigate, collect and assess information as it becomes available to us and are working with consumers who contact us to better understand their particular situation."
Consumers are entitled to a full refund if they return the product.