Your Formula. Your Brand.
- Three categories.
- One certified manufacturer.
- A compliance pathway specific to USA.
Private Label or White Label?
Want a product built to your spec? You’re in the right place.
Choose Your Category
- Biocide
REGULATED BY
US EPA under FIFRA — federal law
WHAT YOU NEED
EPA Establishment Number + Product Registration + approved Master Label + efficacy data. State registration may also apply.
WHO REGISTERS
EPA registrant — Envirocleanse (white label) or your entity (new registration)
TIMELINE
New EPA registration: 12–24 months. White label under Envirocleanse’s registration: 6–12 weeks.
TYPICAL MOQ
1,000–5,000 units first run
COST RANGE
New registration: $20,000–$80,000+. White label: significantly lower.
- Cosmetic
REGULATED BY
FDA under FD&C Act + MoCRA (effective 2023–2024)
WHAT YOU NEED
FDA facility registration (annual) + product listing with FDA + safety substantiation documented + GMP compliance. No pre-market approval needed.
WHO REGISTERS
Brand owner as Responsible Person under MoCRA. Foreign brands must appoint a US Agent.
TIMELINE
3–6 months from brief to FDA-registered, production-ready product
TYPICAL MOQ
500–2,000 units first run
COST RANGE
FDA registration + safety substantiation: $2,000–$5,000. Total first-run budget: $5,000–$20,000+
- Medical
REGULATED BY
FDA as a medical device (21 CFR) or drug — depends on intended use
WHAT YOU NEED
510(k) Premarket Notification + substantial equivalence to predicate device + technical documentation + ISO 13485 / 21 CFR Part 820 QMS + post-market surveillance
WHO REGISTERS
510(k) holder — brand owner or device manufacturer
TIMELINE
510(k) prep: 6–18 months. FDA review: 12–18 months. Total: 18–36+ months.
TYPICAL MOQ
Higher — confirm at enquiry stage
COST RANGE
510(k) prep + submission: $50,000–$200,000+. Not suitable without significant capitalisation.
Your Manufacturing Partner
Every private label product developed through HOCl Hub United States is made by one certified manufacturer.
Envirocleanse
Katy, Texas, USA
CERTIFICATION:
- EPA Registered Disinfectant
- FDA Supported Claims
- Health Canada DIN
- 12-Month Shelf Life Certified
- SDS Documentation compliant
AVAILABLE FOR PRIVATE LABEL
- EPA-registered HOCl disinfectant — broad-spectrum
- Retail HOCl disinfectant sprays
- Bulk HOCl for healthcare, food service, and facilities
Manufactured & Tested to Recognised Standards
Who This Is For
Personal Care & Skincare
Professional Cleaning & Facilities
Healthcare & Clinical
Hospitality & Food Service
Veterinary & Animal Care
Food Service & Agriculture
You don't need a finished brief — just a clear idea of what you want the product to do. The compliance pathway doesn't change based on where you are in your journey, so the earlier you understand it, the better.
What You Need to Know
Minimum order?
Cosmetic and biocide: 500–2,000 units typically. Medical: higher. Exact MOQs confirmed in our first response.
Who owns the compliance?
You, as brand owner, hold legal responsibility. We provide EPA-registered manufacturing and documentation.
What do I need in my brief?
Intended use, target market, volume, and the specific claims you want to make. Claims reviewed at enquiry.
What is MoCRA and does it affect me?
MoCRA is the FDA's 2022 cosmetics reform law — mandatory facility registration and product listing for all cosmetic brands in the US, including startups. It applies to you.
Can I get a sample?
Samples of existing formulations are available. Custom formulation samples are part of the development process.