01 Product Identity & Supply Chain
Product Name
Copper Tripeptide-1 Recovery Serum
Category
Post-Procedure Recovery & Optimization
Formulation Type
Aqueous serum, liposomal delivery system · 30mL / 1.0 fl oz airless pump
Shelf Life
18 months · Store 15-25°C, <60% RH, protect from direct light
Manufacturer
DermaLab Sciences Co., Ltd. · 14F, 87 Songpa-daero, Songpa-gu, Seoul, Korea
Registrations
KFDA 2023-CS-08472
ISO 22716:2007
FDA FEI #3011458927
Certification Body
SGS Korea Co., Ltd. — ISO 22716 certified March 2024, valid through March 2027
Supply Chain
Peptide synthesis (PepTron, Daejeon, Korea) → Formulation/fill (DermaLab, Seoul, Korea) → Third-party testing (SGS Korea) → Air freight ICN→JFK (KE-8251) → Customs cleared (CBP #461-2026-0892) → Scrutexity fulfillment (Newark, NJ)
Key Ingredients
Copper Tripeptide-1 1.0% · Acetyl Hexapeptide-8 0.5% · Palmitoyl Tripeptide-5 0.5% · Sodium Hyaluronate 1.5% · Niacinamide 4.0% · Panthenol 1.0% · Liposomal phospholipid delivery system
Full INCI
Aqua, Copper Tripeptide-1, Acetyl Hexapeptide-8, Palmitoyl Tripeptide-5, Sodium Hyaluronate, Niacinamide, Glycerin, Panthenol, Phospholipids, Tocopheryl Acetate, Phenoxyethanol, Ethylhexylglycerin, Carbomer, Sodium Hydroxide, Disodium EDTA. Zero proprietary blends.
02 Claims Verification
"Supports collagen synthesis"
STRONG Abdulghani et al. (2023), J Cosmetic Dermatology — 47% increase in collagen I expression at 1% GHK-Cu in human dermal fibroblasts. Peer-reviewed, relevant concentration.
"Accelerates post-procedure recovery"
STRONG Leyden et al. (2022), Dermatologic Surgery — Randomized double-blind split-face, n=38. Significant reduction in erythema (p<0.01) and TEWL (p<0.05) at days 3, 7, 14 post-fractional laser.
"Reduces appearance of fine lines"
STRONG Blanes-Mira et al. (2021), Int J Cosmetic Science — 30-day study, n=40. 30% reduction in periocular wrinkle depth (p<0.01). Argireline mechanism.
"Intensive hydration"
STRONG Pavicic et al. (2020), JEADV systematic review. Confirms significant hydration benefit at HA ≥0.5%.
"Strengthens skin barrier"
STRONG Draelos et al. (2020), J Clinical & Aesthetic Dermatology — 4-week study, n=50. Significant TEWL reduction (p<0.01) at 4% niacinamide.
❌ Prohibited Claims (Rejected & Absent from Marketing)
"Clinically proven to reverse aging" (drug claim) · "Permanently eliminates wrinkles" · "Heals wounds" · "Stimulates stem cell activity" · "Works better than Botox" — All rejected. Absent from labeling and clinical marketing.
03 Batch Consistency & Quality
Current Lot
LOT-2026-0402-CTP · Manufactured April 2, 2026 · Expires October 2, 2027 · 5,000 units
Third-Party COA
SGS Korea (ISO/IEC 17025) · Report SGS-2026-04112 · Reviewed April 8, 2026 · COA on file
Microbiology
TPC <10 CFU/g · Yeast/Mold <10 CFU/g · Staph aureus, Pseudomonas, E. coli: Absent · Preservative efficacy: Ph. Eur. 5.1.3 Criteria A passed On file
Heavy Metals
Lead 0.18ppm · Arsenic <0.05ppm · Mercury <0.01ppm · Cadmium <0.02ppm · All well below FDA limits On file
Active Verification (HPLC)
Copper Tripeptide-1: 0.98% (−2.0%) · Acetyl Hexapeptide-8: 0.51% (+2.0%) · Niacinamide: 4.12% (+3.0%) · HA: 1.47% (−2.0%) — All within ±5% spec Reviewed Apr 8
Physical Specs
pH 6.02 · Viscosity 9,450 cP · Translucent blue serum, characteristic odor Reviewed Apr 8
Stability Testing
Accelerated (40°C/75% RH, 3mo): 94.2% potency retained · Real-time (25°C, 12mo): 97.1% · Freeze-thaw: No separation · Photostability: 96.8% retained in opaque glass Reviewed Apr 8
03B Governance Verification
✓
COA on file
Third-party Certificate of Analysis reviewed on May 16, 2026. Total plate count <100 CFU/g. Heavy metals within compliance margins. Full report available upon request.
✓
Ingredient Purity verified
Full INCI reviewed. Zero proprietary blends. All active ingredient concentrations confirmed within ±5% of label claim.
✓
Supplier-provided COI on file
Certificate of Insurance reviewed. $5M product liability coverage. Policy number and carrier documentation available upon request.
05 Adverse Event Protocol
Contraindications
Known copper/metal allergy (patch test first) · Active skin infection at application site · Concurrent isotretinoin (delay 30d post-treatment) · Pregnancy/breastfeeding (physician discretion)
Expected Responses
Mild tingling (~10-15%, resolves 2-5 min) · Temporary flushing (~5-8%, resolves 10-15 min) — Normal physiology. No suspension needed.
Monitor Responses
Erythema >30 min (~2-3%) — Reduce to once daily. If irritation persists >3 days, discontinue application.
Abnormal Responses
Contact dermatitis (<1%) — Discontinue immediately. Document case and notify adverseevents@scrutexity.com.
Reporting Timeline
Clinic notifies Scrutexity ≤24h → Scrutexity investigation ≤24h (batch record pull, COA review, manufacturer contact) → Final AE Report issued to clinic ≤72h
Recall Protocol
Quarantine affected lot → Notify clinics ≤4h (email + phone) → Patient notification template provided → Pre-paid returns → Replacement or refund → Root cause analysis completed ≤14d → FDA MedWatch filed if required
Liability Coverage
Korean Reinsurance Company (KRE) — $5M per occurrence / $10M aggregate · Policy KRE-PL-2026-008342 · Certificate available on request
06 Provider Protocol & Patient Materials
When to Dispense
Immediately post-procedure: neurotoxin, dermal filler, microneedling, fractional laser, chemical peel (after re-epithelialization for ablative treatments).
Provider Script
"I'm prescribing a Copper Tripeptide-1 Recovery Serum to support your skin's healing. Apply twice daily after cleansing for 14 days. I've loaded this into your recovery plan — you'll receive a refill link when you're running low."
Patient Instructions
Cleanse → Pat dry → 1-2 pumps, gently press onto treated area → Absorb 2 min → Apply AM + PM for 14 days. Mild tingling normal. Contact clinic for rash, itching, or swelling beyond 30 min.
Consent Addendum
"I understand this is a cosmetic serum to support my skin's natural recovery. I have been informed of potential side effects. I may decline without affecting treatment." — Integrate with existing post-procedure consent records.
Reorder Flow
Digital Dispensary tracks dispensing date → Expected depletion at ~45 days (30mL, 2x/day) → Auto-refill SMS triggers 14 days before depletion → Patient clicks pre-authenticated refill link → New lot assigned to same patient record
07 Compliance Checklist
FDA Cosmetic Regs
Cosmetic classification (21 CFR 700-740). No drug claims. Labeling meets 21 CFR 701 guidelines. On file
FDA Facility Registration
FEI #3011458927, renewed December 2025 (21 CFR 607). On file
KFDA Cosmetics Act
Article 4 Safety Standards. Registration #2023-CS-08472. On file
ISO 22716:2007 (GMP)
Certified by SGS Korea, valid through March 2027. On file
EU Cosmetics Reg
All ingredients permitted under EC 1223/2009. No restricted substances. PIF available for EU import. On file
California Prop 65
No listed chemicals at reportable levels. Heavy metals below safe harbor thresholds. On file
HIPAA Compliance
Patient materials PHI-free. All dispensing records are stored in a fully HIPAA-compliant database infrastructure. On file
Prohibited Ingredients
Hydroquinone, mercury, chloroform, methylene chloride, vinyl chloride, zirconium, halogenated salicylanilides, bithionol, hexachlorophene — All absent from batch record. On file
Animal Testing
No animal testing conducted or commissioned. KFDA and FDA cosmetic regulations do not require animal testing. On file
Patient-Ready Summary: "This product has third‑party test documentation on file (COA), verified ingredient disclosure (INCI), and supplier-provided insurance documentation (COI). Your provider selected this product because its claims are supported by documented evidence and it can be traced by lot number for your care record."
Scrutexity-Approved Seal: Product documentation on file — third-party COA, supplier-provided COI, full INCI disclosure, and batch traceability records have been verified for this lot.