Search results for “cpnp notification”
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OTC Drug Establishment Registration + Labeler Code (FDA)
Sunscreens, acne treatments, antiperspirants and other OTC monograph drugs are drugs in the US, not cosmetics. The establishment that makes them mu...
View full detailsMoCRA Serious Adverse Event Reporting Service
Under MoCRA, the responsible person must report serious adverse events from US cosmetic use to FDA within 15 business days and keep records for 6 y...
View full detailsMoCRA Facility Registration + US Agent (First Year)
Foreign cosmetic facilities must register with the FDA under MoCRA and name a US agent. This package covers both: we prepare and submit your regist...
View full detailsUS Responsible Person for Cosmetics (12 Months)
Under MoCRA, the responsible person is the company named on a cosmetic's label, with a US address or contact for adverse event reports. Phoenix Saf...
View full detailsMedical Device Label, IFU & UDI Review (FDA)
Medical device labels sold in the US must meet 21 CFR Part 801, and most need a unique device identifier under 21 CFR Part 830. We review your labe...
View full detailsMoCRA Enterprise Annual Package
MoCRA Enterprise is a 12-month programme for brands with 100 or more SKUs or several facilities. It adds a dedicated regulatory manager, a 1-busine...
View full detailsOTC Drug Listing with FDA (NDC), per SKU
Each OTC drug sold in the US, such as a sunscreen or acne treatment, must be listed with FDA and carry a National Drug Code. We prepare the drug li...
View full detailsUS Cosmetic Label Review (MoCRA & FDA)
US cosmetic labels must meet FDA's labelling regulations, the Fair Packaging and Labeling Act and MoCRA, which adds a US contact for adverse event ...
View full detailsUS Agent for Foreign Medical Device Establishments (12 Months)
Foreign medical device establishments must name a US agent who lives or has a place of business in the US, under 21 CFR 807.40. Phoenix Safety Cons...
View full detailsMoCRA Small Business Exemption Check
MoCRA exempts some small businesses from facility registration and product listing, based on average annual US sales over three years, but not for ...
View full detailsGolden Vanilla Coconut Perfume Oil For Women 1101
Quick answer Golden Vanilla Coconut 1101 is a feminine coconut perfume oil sold in bulk from 100 g to 5 kg. Bergamot and coconut open onto jasmine...
View full detailsSweet Strawberry Rose Perfume Oil For Women 1013 Bulk Fragrance Oil
Quick answer Sweet Strawberry Rose 1013 is a feminine berry floral perfume oil sold in bulk from 100 g to 5 kg. Green mandarin and strawberry open...
View full detailsCrisp Cucumber Suede Unisex 1243 Bulk Perfume Oil
Quick answer Crisp Cucumber Suede 1243 is a unisex green perfume supplied ready-mixed for self-filling, in a 5 ml sample, 500 ml and 1000 ml. Cucu...
View full detailsIntense Vanilla Iris Perfume Oil For Men 1071
Quick answer Intense Vanilla Iris 1071 is a masculine vanilla perfume oil sold in bulk from 100 g to 5 kg. Lavender and mint open onto iris and to...
View full detailsFloral Orangeblossom Amber Women 1037 Perfume Oil Bulk Fragrance Oil
Quick answer Floral Orangeblossom Amber 1037 is a feminine floral perfume oil sold in bulk from 100 g to 5 kg. Mandarin and lavender open onto ora...
View full detailsFloral Jasmine Vanilla Women 1025 Perfume Oil Bulk Fragrance Oil
Quick answer Floral Jasmine Vanilla 1025 is a feminine creamy floral perfume oil sold in bulk from 100 g to 5 kg. Gardenia and bergamot open onto ...
View full detailsFresh Citrus Woody Perfume Oil For Men 1055 Bulk Fragrance Oil
Quick answer Fresh Citrus Woody 1055 is a masculine fresh woody perfume oil sold in bulk from 100 g to 5 kg. Bergamot and grapefruit open onto pin...
View full detailsClassic Lavender Vanilla Women 1122 Perfume Oil
Quick answer Classic Lavender Vanilla 1122 is a feminine lavender perfume oil sold in bulk from 100 g to 5 kg. Bergamot and lavender open onto iri...
View full detailsRich Amber Rose Perfume Unisex 1193 Perfume Oil
Quick answer Rich Amber Rose 1193 is a unisex rose perfume oil sold in bulk from 100 g to 5 kg. Grapefruit and bergamot open onto rose and amber, ...
View full detailsMarine Amber Fougère Unisex 1088 Perfume Oil Bulk Fragrance Oil
Quick answer Marine Amber 1088 is a unisex aromatic fougère perfume oil sold in bulk from 100 g to 5 kg. Bergamot and marine notes open onto rosem...
View full detailsClean Juniper Cedar Men 1137 Perfume Oil Bulk Fragrance Oil
Quick answer Clean Juniper Cedar 1137 is a masculine coniferous perfume oil sold in bulk from 100 g to 5 kg. Bergamot and lime open onto juniper a...
View full detailsSweet Cherry Vanilla Unisex 1007 Perfume Oil Bulk Fragrance Oil
Quick answer Cherry Vanilla 1007 is a unisex gourmand perfume oil sold in bulk from 100 g to 5 kg. Cherry and bitter almond open onto Turkish rose...
View full detailsFresh Marine Rosemary Men 1206 Perfume Oil Bulk Fragrance Oil
Quick answer Fresh Marine Rosemary 1206 is a masculine aromatic fougère perfume oil sold in bulk from 100 g to 5 kg. Bergamot and marine notes ope...
View full detailsFresh Peony Rose Women 1046 Perfume Oil Bulk Fragrance Oil
Quick answer Fresh Peony Rose 1046 is a feminine light floral perfume oil sold in bulk from 100 g to 5 kg. Peony, lychee and freesia open onto ros...
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