Products · Cosmetics
Oral care: toothpaste & mouthwash as own brand
Toothpaste, mouthwash and oral rinses — cosmetically classified, with reviewed limits and claims.
INOPREX is a development and manufacturing partner for cosmetic oral care: toothpaste, mouthwashes and oral rinses under Regulation (EC) No 1223/2009. Oral care is a classic borderline field; whitening claims need robust support. We review formulation and claims upfront and document the classification in the PIF.
Product portfolio
- Toothpastes (with/without fluoride)
- Mouthwashes
- Oral rinses
- Dental chewing gums
- Whitening pastes
Regulatory classification
Regulation (EC) No 1223/2009, ISO 22716, PIF and CPNP notification. Permissible claims are reviewed individually (e.g. whitening, sensitivity); curative and disease-related statements are excluded.
INOPREX develops, manufactures and takes on regulatory responsibility — in the role that fits your project. For medical devices we act as the legal manufacturer under EU MDR. For cosmetics and food supplements we either take on the role of the responsible person or the person placing the product on the market, or we manage development and production while your brand remains the market operator. Production runs together with leading contract manufacturers and fillers in the EU. White label uses established, documented formulations (MOQ from 10,000 units per SKU); private label develops an exclusive formulation to your briefing (MOQ project-dependent).
Frequently asked questions
Is toothpaste a cosmetic or a medicinal product?
Both are possible: prophylactic toothpaste with fluoride can be cosmetic; products claiming medical prevention can be medicinal products. We clarify the classification per product before formulation.
Are whitening claims permissible?
Only with robust support (usage tests, evidence of effect) and correct wording; we review every claim under Regulation (EU) No 655/2013.
What MOQ applies?
White label from 10,000 units per SKU; private label project-dependent.
Request your project
Send us your product idea, dosage form and target market via the contact form — we will respond within two working days with an initial assessment.