Methylparaben
Excipient (pharmacologically inactive substance)
What is it?
Methylparaben has been used as a preservative in the food, cosmetic, and pharmaceutical industries for over 50 years. The chemical formula for methyl paraben is C8H8O3. It is also found naturally in fruits like blueberries where it has antimicrobial activity.
Methylparaben is completely absorbed through the skin or after ingestion, and it is hydrolyzed to para-hydroxybenzoic acid, and metabolites are rapidly excreted in the urine. There is no evidence of accumulation. It is on the FDA generally regarded as safe list.
Acute toxicity studies in animals indicate that methylparaben is practically non-toxic by both oral and injectable routes. It has not been shown to be teratogenic, carcinogenic, mutagenic or embryotoxic.
It does not appear to be irritating when used topically, although some people may show cross-sensitivity if allergic to local anesthetics that are metabolized to para-aminobenzoic acid. Cases of local contact dermatitis have been reported.[1][2][3] 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%.[4]
[1] US Department of Labor. OSHA. Safety and Health Topics. Methylparaben. Accessed 8/17/2012 http://www.osha.gov/dts/chemicalsampling/data/CH_254445.html
[2] FDA’s SCOGS database; methylparaben; SCOGS-Report Number: 8; Accessed 8/17/2012. http://www.accessdata.fda.gov/scripts/fcn/fcnDetailNavigation.cfm?rpt=scogsListing&id=210
[3] Soni MG, Taylor SL, Greenberg NA, et al. Evaluation of the health aspects of methyl paraben: a review of the published literature. Food Chem. Toxicol. 40:1335-73. Accessed 8/17/2012 http://www.sciencedirect.com/science/article/pii/S0278691502001072
[4] US Food and Drug Administration. Cosmetics. Parabens. Accessed 8/19/2012. http://www.fda.gov/cosmetics/productandingredientsafety/selectedcosmeticingredients/ucm128042.htm
Top Medications with this excipient
- Amoxicillin 500 mg (Teva Pharmaceuticals USA)
- Benzonatate 200 mg (Major Pharmaceuticals Inc.)
- Benzonatate 100 mg (Zydus Pharmaceuticals)
- Benzonatate 200 mg (Zydus Pharmaceuticals)
- Chlordiazepoxide Hydrochloride 10 mg (Teva Pharmaceuticals USA)
- Diphenhydramine Hydrochloride 25 mg (Perrigo Company)
- Fluoxetine Hydrochloride 20 mg (Barr Laboratories, Inc.)
- Morphine Sulfate SR 30 mg (Endo Pharmaceuticals Inc.)
- Morphine Sulfate SR 60 mg (Endo Pharmaceuticals Inc.)
- Morphine Sulfate SR 15 mg (Endo Pharmaceuticals Inc.)
- Morphine Sulfate SR 100 mg (Endo Pharmaceuticals Inc.)
- Nortriptyline Hydrochloride 25 mg (Teva Pharmaceuticals USA)
- Opana ER 30 mg (Endo Pharmaceuticals Inc.)
- Opana ER 15 mg (Endo Pharmaceuticals Inc.)
- Oxazepam 15 mg (Actavis)
- Phenytoin Sodium Extended 100 mg (Taro Pharmaceuticals U.S.A., Inc.)
- Temazepam 15 mg (Sandoz Pharmaceuticals Inc.)
- Temazepam 30 mg (Sandoz Pharmaceuticals Inc.)
- Tylenol Extra Strength 500 mg (McNeil Consumer)
- Vimovo esomeprazole 20 mg / naproxen 500 mg (AstraZeneca Pharmaceuticals)
