Esokalli Testosterone Booster Oral Dissolving Film
3d710111-debf-ff99-e063-6294a90a3186
HUMAN OTC DRUG LABEL
Sep 1, 2025
Guangzhou Yixin Cross-border E-commerce Co., Ltd.
DUNS: 455800881
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Esokalli Testosterone Booster Oral Dissolving Film
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses
For the treatment of erectile dysfunction (ED)
COMPONENTS
Active ingredients (in each film)
Tadalafil 30 mg – Erectile dysfunction treatment
Vardenafil 10 mg – Erectile dysfunction treatment
OTC - PURPOSE SECTION
Purpose
Phosphodiesterase type 5 (PDE5) inhibitors
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Contraindications
Not for use in pregnant or breastfeeding women
Not for use in children under 18 years
WARNINGS SECTION
Warnings
For adult men only.
DOSAGE & ADMINISTRATION SECTION
Dosage and administration
• Take 1 oral film as a single dose.
• Administer orally by placing on the tongue until dissolved.
• Administer approximately 0.5 to 4 hours prior to anticipated sexual
activity.
• Do not exceed 1 dose in 24 hours.
OTC - DO NOT USE SECTION
Do not use if you:
take nitrate medicines (such as nitroglycerin)
have severe heart disease or very low blood pressure
are allergic to tadalafil, vardenafil, or any ingredient in this product
have galactose intolerance, total lactase deficiency, or glucose-galactose
malabsorption
OTC - WHEN USING SECTION
When using this product you may experience:
headache, flushing, indigestion, nasal congestion, dizziness, muscle pain, back pain, nausea, rash, or visual disturbances
OTC - STOP USE SECTION
Stop use and ask a doctor if:
you experience chest pain, fainting, sudden vision or hearing loss
an erection lasts longer than 4 hours (priapism). This is a medical emergency.
INACTIVE INGREDIENT SECTION
Inactive ingredients
Film-forming polymers, stabilizers, sweeteners, flavoring agents.