{"product_id":"otc-drug-facts-label-review-monograph-conformity","title":"OTC Drug Facts Label Review (Monograph Conformity)","description":"\u003cp\u003eOTC drugs such as sunscreens, acne treatments and antiperspirants must carry a Drug Facts label in the format set by 21 CFR 201.66, with wording that matches the relevant OTC monograph. We review active ingredients, uses, warnings, directions, claims and the principal display panel, and mark up required changes. Laboratory testing is excluded. £795 per SKU.\u003c\/p\u003e\u003ch2\u003eWhat is a Drug Facts label?\u003c\/h2\u003e\u003cp\u003eEvery \u003cstrong\u003eOTC drug\u003c\/strong\u003e in the US must carry a \u003cstrong\u003eDrug Facts\u003c\/strong\u003e panel in the standard format of \u003cstrong\u003e21 CFR 201.66\u003c\/strong\u003e: active ingredients, purpose, uses, warnings, directions, other information and inactive ingredients. Wording must match the applicable \u003cstrong\u003eOTC monograph\u003c\/strong\u003e under \u003cstrong\u003eFD\u0026amp;C Act section 505G\u003c\/strong\u003e, such as \u003cstrong\u003eM020 for sunscreens\u003c\/strong\u003e or \u003cstrong\u003eM019 for antiperspirants\u003c\/strong\u003e. Sunscreen claims like \u003cstrong\u003eSPF\u003c\/strong\u003e, \u003cstrong\u003ebroad spectrum\u003c\/strong\u003e and \u003cstrong\u003ewater resistant\u003c\/strong\u003e need test evidence.\u003c\/p\u003e\u003ch3\u003eWhat's included in your Drug Facts review?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFormat check\u003c\/strong\u003e: Headings, order, type size and layout under 21 CFR 201.66\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMonograph conformity\u003c\/strong\u003e: Active ingredient, strength, uses and warnings against the monograph\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eClaims check\u003c\/strong\u003e: Claims beyond the monograph flagged\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePrincipal display panel\u003c\/strong\u003e: Identity, net quantity and, for sunscreens, SPF and broad spectrum statements\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecheck\u003c\/strong\u003e: One recheck of the revised label\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this review for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBrands selling sunscreen, acne, antiperspirant or anti-dandruff products in the US\u003c\/li\u003e\n\u003cli\u003eUK and EU brands converting labels for the US\u003c\/li\u003e\n\u003cli\u003eAmazon US sellers asked to fix drug labels\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this review not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eLaboratory testing.\u003c\/strong\u003e Laboratory testing, lab fees and test reports are not included. SPF, broad spectrum and water resistance claims need test evidence.\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eLabel design.\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegistration and listing.\u003c\/strong\u003e Available separately.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eNon-monograph drugs\u003c\/strong\u003e needing an NDA.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does OTC Drug Facts Label Review work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your label\u003c\/strong\u003e: Every panel, the formula and test reports for claims.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview\u003c\/strong\u003e: We check format, monograph wording and claims.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReport\u003c\/strong\u003e: You receive a marked-up label.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecheck\u003c\/strong\u003e: One recheck is included.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch3\u003eWhat US law and FDA rules apply?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR 201.66\u003c\/strong\u003e — Drug Facts format and content\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 505G\u003c\/strong\u003e — OTC monographs\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eOTC Monograph M020\u003c\/strong\u003e — sunscreen drug products\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eOTC Monograph M019\u003c\/strong\u003e — antiperspirant drug products\u003c\/li\u003e\n\u003cli\u003eOfficial sources:\u003c\/li\u003e\n\u003cli\u003e[Drug Registration and Listing System (FDA)](https:\/\/www.fda.gov\/drugs\/guidance-compliance-regulatory-information\/electronic-drug-registration-and-listing-system-edrls)\u003c\/li\u003e\n\u003cli\u003e[OTC Monograph Drug User Fee Program (FDA)](https:\/\/www.fda.gov\/industry\/fda-user-fee-programs\/over-counter-monograph-drug-user-fee-program-omufa)\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eRelated services\u003c\/h3\u003e\u003cp\u003eBrowse \u003ca href=\"\/fr\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/fr\/products\/otc-drug-establishment-registration-labeler-code-fda\"\u003eOTC Drug Establishment Registration + Labeler Code (FDA)\u003c\/a\u003e, \u003ca href=\"\/fr\/products\/otc-drug-listing-with-fda-ndc-per-sku\"\u003eOTC Drug Listing with FDA (NDC), per SKU\u003c\/a\u003e, \u003ca href=\"\/fr\/products\/us-cosmetic-label-review-mocra-fda\"\u003eUS Cosmetic Label Review (MoCRA \u0026amp; FDA)\u003c\/a\u003e.\u003c\/p\u003e\u003cp\u003ePrepared by \u003cstrong\u003ePhoenix Compliance Services\u003c\/strong\u003e and reviewed by \u003cstrong\u003e\u003ca href=\"https:\/\/www.linkedin.com\/in\/shamuelshees\" rel=\"author\"\u003eSyed Muhammad Shamuel Shees\u003c\/a\u003e, US Regulatory Lead\u003c\/strong\u003e, with US agent and responsible person roles provided by Phoenix Safety Consultants LLC (USA), a sister company of Phoenix Compliance Services. FDA fees are not included and are passed through where they apply.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Default Title","offer_id":67824343646285,"sku":null,"price":795.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/otc-drug-facts-label-review-monograph-conformity.webp?v=1793176385","url":"https:\/\/phoenixcosmeticsafety.com\/fr\/products\/otc-drug-facts-label-review-monograph-conformity","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}