Diphenhydramine HCl

What Is It?

In cosmetics and personal care products, Diphenhydramine HCl may be used in the formulation of tonics, dressings, and other hair grooming aids.

Why Is It Used?

Diphenhydramine HCl enhances the appearance and feel of hair, by increasing hair body, suppleness, or sheen, or by improving the texture of hair that has been damaged physically or by chemical treatment. In OTC drug products, Diphenhydramine HCl, functions as an antiemetic and an anithistamine.

Scientific Facts

In OTC drug products, Diphenhydramine HCl is used as an antihistamine and a sedative. Diphenhydramine HCl also has local anesthetic properties, and has been used for patients allergic to common local anesthetics like lidocaine.

Safety Information

The Food and Drug Administration (FDA) has reviewed the safety of Diphenhydramine HCl and permits its use as an active ingredient in Over-The-Counter (OTC) antiemetic, nighttime sleep-aid, cold, cough, allergy, bronchodilator, and antiasthmatic drug products. Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.

Link to FDA Code of Federal Regulations for Diphenhydramine Hydrochloride

Diphenhydramine and its salts, including Diphenhydramine HCl, are listed in the Cosmetics Directive of the European Union and must not form part of the composition of cosmetics and personal care products (see Annex II).

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

Health Canada does not permit the use of Diphenhydramine HCl in cosmetics and personal care products.

Please check the Health Canada website at http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-cri…
for additional information.

More Scientific Information

Diphenhydramine HCl is an amine salt. In cosmetics and personal care products, Diphenhydramine HCl functions as a hair conditioning agentIngredients that enhance the appearance and feel of hair, by increasing hair body, suppleness, or sheen, or by improving the texture of hair that has been damaged physically or by chemical treatment..

Resources

Find out more about the regulation of over-the-counter drugs by the Food and Drug Administration

OTC Drug Home Page: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSa…

Information about OTC Drug monographs: https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/