Rash Creams

Nappy rash is caused by a number of factors including constant moisture, rubbing of the skin, ammonia, faeces and irritants. Secondary nappy rash infection with Candida albicans (a yeast) or bacteria can occur. [1] Rashes are painful, need to be treated quickly and seeking medical advice is a priority if they worsen.

The purpose of rash creams is to create a barrier between the skin and moisture. They may be used for both babies and those that are incontinent.

With adequate agitation (correct loading), a mainstream detergent and warm-hot water, all rash creams will wash out of nappies. Plant based/ sensitive/ eco detergents will not remove these products as well as mainstream detergents. If in doubt check if it washes out of a microfleece liner first.

Formulation Of Rash Creams

Many rash creams are anhydrous or oil based (no water) and are designed to form a film on the skin, creating a waterproofing effect. The film-forming and oil-thickening ingredients, such as Bees Wax (Cera Alba), Polyethylene, Micrcocrystalline wax, Butylated PVP, in combination with the oils themselves, are what create the barrier. The higher these ingredients are listed on the labelling, the more of them the product contains and the thicker and more viscose the product is. The type of emulsion (oil in water, water in oil or oil only) and raw materials used are what determine how thick the product is.

 

When using powders (e.g. talc), please ensure that you and your child do not inhale the product. [2]

Formulation Safety And Regulatory Requirements

The National Industrial Chemicals Notification and Assessment Scheme of Australia regulations require ingredients of a product to be listed on the packaging [2] [3].
Where no ingredients are listed, (most) of the products are either products Listed (Aust L) or Registered (Aust R) with the Therapeutic Goods Administration of Australia (TGA).

Listed therapeutic products are all unscheduled medicines with well-known low-risk ingredients, usually with a long history of use, such as vitamin and mineral products or sunscreens. These are assessed by the TGA for quality and safety but not efficacy. [5] A Registered therapeutic product is one that treats more serious illnesses eg. all prescription medicines, most over the counter medicines such as anti-fungal treatments and some complementary medicines. These are assessed for safety, quality and efficacy. Aust L and Aust R products are not required to provide full ingredient listings on the packaging and must have valid stability, preservative testing, stability and claim data.

Preservative testing is done in accordance to the Appendix XVI.C of the British Pharmacopoeia or Chapter 5.1.3 of the European Pharmacopoeia or Chapter <51> of the United States Pharmacopoeia-National Formulary, [6] testing a products ability to preserve against Candida albicans (a yeast), Aspergillus niger (a fungus), Escherichia coli (a bacteria), Pseudomonas aeruginosa (a water borne bacteria) and Staphylococcus aureus (a bacteria). [7]

The Importance Of Preservation Of Rash Creams

Personal care products are not made or used in sterile conditions and will inevitably grow microbes.
Preservative free rash creams can be potentially be very harmful, they are bombarded with bacteria more than any other product as they are continually exposed to fresh bacteria when fingers come into contact with the tub or tube.

The major problem with preservative free products is that they do not have enough antimicrobial power to act as a complete preservative by themselves and contamination may occur during use. In the case of a rash cream this results in recontamination of a babies skin or rash (eg. reoccurring fungal infections). This is particularly true when the product is completely preservative free.

Anhydrous or oil based products offer minimal potential contamination by bacteria, moulds or yeast due to the lack of water, which may prevent growth of water borne bacteria.  Certain types of packaging can prevent the contamination of a product with microbes eg. single use only. But as a general theory, preservative free products should not be recommended for use on babies, especially as rash creams, as all have a potential for contamination.

Examples of contaminated creams and wipes

[http://microbiology.publish.csiro.au/?act=view_file&file_id=MA10195.pdf]

A Word About Parabens

Parabens are a type of preservative used in cosmetic and pharmaceutical products that have been used safely for decades. [9]
In the community there is widespread concern about parabens in skin care products. This concern came about as a result of media attention focused on one particular article:  “Concentrations of Parabens in Human Breast Tumors”, Dabre PD. Et al, Journal of Applied Toxicology, 24, 5-13 (2004). Reports proliferated about the dangers of parabens. The scientific community thoroughly refuted [10] [11] the claims made by Dabre, pointing out the poor science used in the methodology and conclusions.

Recent evidence also shows that while parabens may have weak estrogenic activity, this activity is short lived and they do not accumulate in the body [12].  At this stage, and despite many studies which prove their safety, no regulatory authority has limited or banned the use of parabens in cosmetics or foods, citing their benefits and lack of adverse findings.  Blueberries, potatoes and other fruits and vegetables naturally contain parabens.
Despite overwhelming evidence that parabens do not have negative effects on human health, the public still appear to consider any product containing them to be harmful. As a result many companies have used consumer fear as a marketing tactic and removed them from their products without any reasonable need to, which further perpetuates the myth.

 

 

References

[1] Baby products position paper, The Australian Society of Cosmetic Chemists (2001)

[2] Handbook of Cosmetic Science and Technology, fourth edition

[3] http://www.nicnas.gov.au/chemical-information/cosmetics

[4] http://www.nicnas.gov.au/communications/publications/information-sheets/existing-chemical-info-sheets/chemicals-commonly-used-in-cosmetics-factsheet-1/?a=5618

[5] http://www.productsafety.gov.au/content/index.phtml/tag/ingredientslabelling

[6] https://www.tga.gov.au/listed-medicines

[7] https://www.tga.gov.au/book/9-stability-finished-product

[8] http://www.pharmacopeia.cn/v29240/usp29nf24s0_c51.html

[9] Handbook of Cosmetic Science and Technology, fourth edition

[10] Preservatives Used in Personal Care Products, The Australian Society of Cosmetic Chemists (2001)

[11] http://www.nicnas.gov.au/communications/publications/information-sheets/existing-chemical-info-sheets/chemicals-commonly-used-in-cosmetics-factsheet-1

[12] http://www.fda.gov/cosmetics/productsingredients/ingredients/ucm128042.htm

[13] http://www.ncbi.nlm.nih.gov/pubmed/19101832