Objectives: Clinical research often uses non-marketed (blinded) labeling. This research evaluated the effect of such labeling on clinical response with peroxide-containing whitening strips. Methods: Healthy adults were randomly assigned 6% hydrogen peroxide whitening strips in experimental-labeled (blinded white pouches and boxes) or marketed (open-label) packaging. Maxillary teeth were treated twice daily for 30 minutes. All use was unsupervised over a 14-day period. Efficacy (L*a*b* color change) was measured objectively by digital image analysis, and safety was assessed from clinical examination and subject report at baseline and end-of-treatment. Results: A total of 20 adults completed the 14-day study and were evaluated. Mean (SD) age was 35.5 (5.98) years, most (95%) were female, and 25% used tobacco products. After 14-days treatment, all subjects (100%) had a measured two-parameter (b* & L*) color improvement. Both groups showed statistically significant improvement from baseline (p < 0.001) in yellowness (Db*) and brightness (DL*). After adjusting for age and baseline color, mean Db* (SE) for open-label strips was –2.47 (0.310) compared to –2.78 (0.347) for the experimental labeled strips. Treatments did not differ significantly (p > 0.546) on Db* at Day 15. Results were similar for DL*, again, with no significant (p > 0.233) between-group differences based on labeling. Mild and transient tooth sensitivity (25%) and oral irritation (25%) represented the most common adverse events in both groups. Clinical examination was unremarkable. Conclusion: In this clinical research, labeling and packaging conditions (experimental versus open-label) did not significantly impact on whitening effectiveness or safety.

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