{"id":293,"date":"2025-06-11T20:07:57","date_gmt":"2025-06-11T20:07:57","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-news\/?p=293"},"modified":"2025-06-11T20:07:57","modified_gmt":"2025-06-11T20:07:57","slug":"antiperspirant-drug-fda-regulations","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-news\/2025\/06\/11\/antiperspirant-drug-fda-regulations\/","title":{"rendered":"ANTIPERSPIRANT DRUG FDA REGULATIONS"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">US FDA regulates <a href=\"https:\/\/www.fdahelp.us\/fda_otc\/antiperspirant.html\">Antiperspirants<\/a>\nas OTC drugs because of their active ingredients block sweat glands. On the\ncontrary deodorants are considered as <a href=\"https:\/\/www.fdahelp.us\/fda-mocra-registration-listing-cosmetic-facility.html\">cosmetics<\/a>\nand mainly intended to mask the body odor.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">As per FDA\u2019s <a href=\"https:\/\/www.fdahelp.us\/otc-drug-products.html\">OTC Drug<\/a> Monograph for\nantiperspirants (M019), these products must follow FDA regulations to follow safety\nand effectiveness.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Active Ingredients<\/strong>: Only\ncertain aluminum-based compounds are permitted, such as aluminum chloride,\naluminum chlorohydrate, and various aluminum zirconium salts, with\nconcentration limits ranging from 15% to 25% depending on the compound.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Labeling<\/strong>: Principal display panel must be marked as\n&#8220;antiperspirants&#8221; and include specific usage directions, such as\n&#8220;apply to underarms only,&#8221; and warnings like &#8220;Do not use on\nbroken skin&#8221; and &#8220;Stop use if rash or irritation occurs&#8221; <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Finished dosage form of antiperspirants may vary in effectiveness\nbecause of difference in formulation. Manufacturers must follow FDA\u2019s\nguidelines to make sure the effectiveness of the antiperspirant. &nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Since antiperspirants are considered as OTC drugs, the\nmanufacturer must comply with all drug requirements such as <a href=\"https:\/\/www.fdahelp.us\/fda-drug-registration.html\">establishment\nregistration<\/a>, <a href=\"https:\/\/www.fdahelp.us\/fda-labeler-code.html\">drug\nlisting<\/a> and labeling requirements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Also, the manufacturers and contract manufacturers must pay <a href=\"https:\/\/www.fdahelp.us\/fda-otc-drug-fees-2025.html\">OMUFA<\/a> fee every\nyear.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">Liberty Management Group<\/a> , as a leading FDA consultant with provide assistance \u00a0with drug <a href=\"https:\/\/www.fdahelp.us\/fda-drug-registration.html\">establishment registration<\/a>, drug listing and <a href=\"https:\/\/www.fdahelp.us\/fda-label-review.html#1review\">label review<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sudha S<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Regulatory Consultant<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email: office@libertymanagement.us<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">www.fdahelp.us<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>US FDA regulates Antiperspirants as OTC drugs because of their active ingredients block sweat glands. On the contrary deodorants are considered as cosmetics and mainly intended to mask the body odor. As per FDA\u2019s OTC Drug Monograph for antiperspirants (M019), these products must follow FDA regulations to follow safety and effectiveness. Active Ingredients: Only certain &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-news\/2025\/06\/11\/antiperspirant-drug-fda-regulations\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;ANTIPERSPIRANT DRUG FDA REGULATIONS&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26],"tags":[42],"class_list":["post-293","post","type-post","status-publish","format-standard","hentry","category-fda-registration-drug","tag-fda-drug-registration"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/293","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/comments?post=293"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/293\/revisions"}],"predecessor-version":[{"id":294,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/293\/revisions\/294"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/media?parent=293"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/categories?post=293"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/tags?post=293"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}