Teoxane RHA Collection
The Teoxane RHA Collection is a family of BDDE-cross-linked sodium hyaluronate gels with product-specific concentrations, anesthetics, presentations, and US indications. RHA means Resilient Hyaluronic Acid in Teoxane’s naming; it does not make the four formulations interchangeable.
This page uses current United States FDA records and US product information as its primary scope.
Quick reference
Section titled “Quick reference”| Field | US family context |
|---|---|
| Regulatory identity | Class III dermal implants under PMA P170002 |
| Current formulation set | RHA Redensity, RHA 2, RHA 3, and RHA Dynamic Volume |
| HA system | Bacterial-fermentation sodium hyaluronate cross-linked with BDDE |
| Current US anesthetic | Mepivacaine in the formulations distributed by Revance |
| PMA applicant and manufacturer | Teoxane S.A. |
| US commercial role | Revance Therapeutics, Inc. distributes the collection |
The FDA’s current device listing preserves both lidocaine and mepivacaine names, while Revance’s current product information states that it distributes the mepivacaine collection and may omit Mepi from the displayed product name. Approval, listing, naming, and current distribution are therefore related but different facts (FDA device listing 🔗; Revance RHA Collection 🔗).
Current US formulation and presentation
Section titled “Current US formulation and presentation”| Current commercial name | Sodium hyaluronate and anesthetic | Syringe and supplied needles |
|---|---|---|
| RHA Redensity | 15 mg/g; 0.3% mepivacaine hydrochloride | 1 mL; two 30 G × ½-inch needles |
| RHA 2 | 23 mg/g; 0.3% mepivacaine hydrochloride | 1 mL; two 30 G × ½-inch needles |
| RHA 3 | 23 mg/g; 0.3% mepivacaine hydrochloride | 1 mL; two 27 G × ½-inch needles |
| RHA Dynamic Volume | 23 mg/g; 0.3% mepivacaine hydrochloride | 1.2 mL; two 27 G × ½-inch needles |
The FDA SSED for the Mepi formulations describes bacterial-fermentation sodium hyaluronate, BDDE crosslinking, physiological buffer at pH 7.3, the concentrations, and the supplied syringe–needle configurations. It identifies RHA Redensity as the least cross-linked and RHA 4 Mepi as the most cross-linked among the four assessed formulations (FDA Mepi SSED 🔗).
RHA Dynamic Volume is the mepivacaine formulation formerly identified commercially as RHA 4 Mepi. Its current FDA labeling records 23 mg/g sodium hyaluronate, 0.3% mepivacaine, and the 1.2 mL presentation (FDA RHA Dynamic Volume labeling 🔗; Teoxane availability announcement 🔗).
These fields document composition and presentation. They do not create a concentration or crosslinking hierarchy for clinical performance.
US indications remain product-specific
Section titled “US indications remain product-specific”All indications below apply to adults aged 22 years or older.
| Product | FDA-labeled objective and anatomy | Labeled placement context |
|---|---|---|
| RHA Redensity | Moderate to severe dynamic perioral rhytids | Dermis and superficial dermis of the face |
| RHA 2 | Moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds | Mid-to-deep dermis |
| RHA 3 | Dynamic facial wrinkles and folds such as nasolabial folds; lip augmentation and fullness through the vermilion body, vermilion border, and oral commissures | Mid-to-deep dermis for wrinkles and folds; product-specific lip labeling |
| RHA Dynamic Volume | Dynamic facial wrinkles and folds such as nasolabial folds; cheek augmentation and/or age-related midface contour deficiencies | Deep dermis to superficial subcutaneous tissue for wrinkles and folds; subcutaneous to supraperiosteal layers for the midface |
The FDA approved the original RHA 2, 3, and 4 wrinkle-and-fold indications under P170002, RHA Redensity under S012, and the RHA 3 lip indication under S030. The Mepi formulations were approved under S026, and the current RHA product information carries the product-specific indication set forward (FDA original RHA PMA 🔗; FDA RHA Redensity supplement 🔗; FDA RHA 3 lip supplement 🔗; FDA Mepi approval letter 🔗; current US RHA indications 🔗).
The FDA expanded RHA 4 and RHA Dynamic Volume to cheek augmentation and age-related midface contour correction on September 18, 2025 (FDA P170002/S048 🔗). The later commercial launch does not change the approval date.
Read Preserved Network Technology as an attributed term
Section titled “Read Preserved Network Technology as an attributed term”Teoxane and Revance call the RHA manufacturing system Preserved Network Technology (PNT) and describe it as a heatless, homogeneous process intended to limit HA-chain fragmentation during manufacturing (Revance RHA technology 🔗; Teoxane RHA technology 🔗).
PNT is a manufacturer technology name, not an independent regulatory class. It should not be translated into a class-wide promise of more natural movement, superior integration, greater safety, easier injection, or longer duration. The exact formulation and label still govern each variant.
Nor should the four formulations be ranked using isolated rheology values. The rheology foundation explains why instrument settings and test conditions must travel with every measurement.
Mepivacaine changed the commercial names—not every field
Section titled “Mepivacaine changed the commercial names—not every field”The FDA approved RHA Redensity Mepi, RHA 2 Mepi, RHA 3 Mepi, and RHA 4 Mepi on October 13, 2023. The SSED states that the compared lidocaine and mepivacaine versions differ in anesthetic agent while retaining their corresponding HA formulation; the two anesthetics still carry distinct hypersensitivity and labeling considerations (FDA Mepi approval and SSED 🔗).
Revance announced the US commercial switch to the mepivacaine collection in 2025 and now states that only those formulations are distributed by Revance. A practitioner should therefore record the exact carton and anesthetic rather than infer it from a shortened product name (Revance launch announcement 🔗; current RHA product information 🔗).
Regional naming boundary
Section titled “Regional naming boundary”The original FDA SSED states that RHA 2, RHA 3, and RHA 4 were marketed in Europe and other markets as Teosyal RHA 2, Teosyal RHA 3, and Teosyal RHA 4 at that time (FDA original RHA SSED 🔗). This supports a documented family relationship; it does not prove that every current Teosyal presentation is identical to the current US product.
Do not automatically map:
- RHA Redensity to a numbered Teosyal product
- RHA Dynamic Volume to every product carrying
RHA 4in another market - a lidocaine presentation to the current US mepivacaine presentation
- Teosyal RHA Kiss or other non-US variants into the US approval matrix
Concentration, anesthetic, syringe volume, indication, placement, and current availability must be checked from the local document.
Company and regulatory roles
Section titled “Company and regulatory roles”| Role | Supported relationship |
|---|---|
| PMA applicant | Teoxane S.A. holds the P170002 applicant role in FDA records |
| Manufacturer | Current US labeling names Teoxane S.A. in Geneva, Switzerland |
| Trademark | Current labeling states that RHA is a registered trademark of Teoxane S.A. |
| US distributor | Current labeling and product information name Revance Therapeutics, Inc. |
| Parent-company context | Crown Laboratories completed its acquisition of Revance Therapeutics on February 6, 2025; the combined company later announced that it operates under the Revance name |
Sources: FDA RHA Dynamic Volume labeling 🔗, Revance–Teoxane partnership 🔗, Crown acquisition completion 🔗, and combined-company naming announcement 🔗.
These roles should not be compressed into the claim that Revance manufactures RHA or that the FDA applicant necessarily controls distribution in every market.
Safety and hyaluronidase boundary
Section titled “Safety and hyaluronidase boundary”The current labeling describes expected injection-site responses including redness, swelling, pain, tenderness, firmness, lumps or bumps, bruising, discoloration, and itching. It also warns that unintended intravascular injection can cause embolization, vascular occlusion, ischemia, infarction, skin necrosis, vision impairment or blindness, and stroke. Contraindications include severe allergy histories, relevant bacterial-protein or amide-local-anesthetic hypersensitivity, and bleeding disorders; the exact anesthetic matters (FDA RHA 2 Mepi labeling 🔗; FDA RHA Dynamic Volume labeling 🔗).
Hyaluronidase may degrade HA gels, but product response varies with the gel, enzyme, exposure, amount, timing, anatomy, and clinical event. HA filler does not mean that elective correction or an emergency has a guaranteed simple reversal pathway.
Related foundation pages
Section titled “Related foundation pages”- Hyaluronic Acid Fillers explains the family-level scope.
- Formulation and Gel Architecture explains why concentration, crosslinker, anesthetic, and syringe presentation are separate fields.
- Rheology and Physical Properties sets the method requirements for comparing laboratory measurements.