Medically reviewed by Drugs.com. Last updated on Sep 22, 2021.
Excipient (pharmacologically inactive substance)
What is it?
Propylparaben has been used as an antimicrobial preservative in the food, cosmetic, and pharmaceutical industries for over 50 years. The chemical formula for propylparaben is C10H12O3.
Propylparaben is easily absorbed through the gastrointestinal tract and skin, and metabolites are rapidly excreted in the urine. It does not appear to accumulate in the body. It is on the FDA generally regarded as safe list.
Animal toxicity studies suggest propylparaben is relatively nontoxic by both the oral and injectable routes, but may irritate the skin It has not been shown to be carcinogenic, mutagenic or clastogenic. All parabens have similar structure to estrogen. Studies conducted in the early 2000s located traces of parabens in breast tumors, but evidence has not linked parabens with breast cancer.
The Cosmetic Ingredient Review (CIR) reviewed the safety of methylparaben, propylparaben, and butylparaben in 1984 and concluded they were safe for use in cosmetic products at levels up to 25%. Typically parabens are used at levels ranging from 0.01 to 0.3%.
Top medications with this excipient
- Acetaminophen 325 mg
- Acetaminophen 500 mg
- Benzonatate 100 mg
- Benzonatate 100 mg
- Diphenhydramine Hydrochloride 25 mg
- Disopyramide Phosphate 150 mg
- Gentle Laxative bisacodyl 5 mg
- Lopid 600 mg
- Loxapine Succinate 25 mg
- Loxapine Succinate 50 mg
- Methylergonovine Maleate 0.2 mg
- Oxazepam 10 mg
- Oxazepam 15 mg
- Phenytoin Sodium 100 mg
- Seromycin 250 mg
- Temozolomide 180 mg
- Temozolomide 5 mg
- Tylenol Extra Strength 500 mg
- Valproic Acid 250 mg
- Vimovo esomeprazole 20 mg / naproxen 375 mg
- Soni MG, Burdock GA, Taylor SL, et al. Safety assessments of propyl paraben: a review of the published literature. Food Chem. Toxicol. 39:513-32. Accessed 8/16/2012
- Dave RH. Overview of pharmaceutical excipients used in tablets and capsules. Drug Topics (online). Advanstar. 10/24/2008. Accessed 08/17/2011. http://drugtopics.modernmedicine.com/drugtopics/Top+News/Overview-of-pharmaceutical-excipients-used-in-tabl/ArticleStandard/Article/detail/561047
- FDA’s SCOGS database; propylparaben; SCOGS-Report Number: 8; Accessed 8/17/2012. http://www.accessdata.fda.gov/scripts/fcn/fcnDetailNavigation.cfm?rpt=scogsListing&id=261
- US Food and Drug Administration. Cosmetics. Parabens. Accessed 8/19/2012. http://www.fda.gov/cosmetics/productandingredientsafety/selectedcosmeticingredients/ucm128042.htm
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