ESOKALLI TESTOSTERONE BOOSTER ORAL DISSOLVING FILM- esokalli testosterone booster oral dissolving film film, soluble 
Guangzhou Yixin Cross-border E-commerce Co., Ltd.

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Active ingredients (in each film)

Tadalafil 40 mg – Erectile dysfunction treatment
Vardenafil 20 mg – Erectile dysfunction treatment

Purpose

Phosphodiesterase type 5 (PDE5) inhibitors

Uses

For the treatment of erectile dysfunction (ED)

Warnings

For adult men only.

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

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.

When using this product you may experience:

headache, flushing, indigestion, nasal congestion, dizziness, muscle pain, back pain, nausea, rash, or visual disturbances

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.

Contraindications

Not for use in pregnant or breastfeeding women
Not for use in children under 18 years

Inactive ingredients

Film-forming polymers, stabilizers, sweeteners, flavoring agents.

PRINCIPAL DISPLAY PANEL

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ESOKALLI TESTOSTERONE BOOSTER ORAL DISSOLVING FILM 
esokalli testosterone booster oral dissolving film film, soluble
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84778-085
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL40 mg  in 100 mg
VARDENAFIL (UNII: UCE6F4125H) (VARDENAFIL - UNII:UCE6F4125H) VARDENAFIL20 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84778-085-011 in 1 BOX08/24/2025
160 mg in 1 PATCH; Type 0: Not a Combination Product
2NDC:84778-085-022 in 1 BOX08/24/2025
260 mg in 1 PATCH; Type 0: Not a Combination Product
3NDC:84778-085-034 in 1 BOX08/24/2025
360 mg in 1 PATCH; Type 0: Not a Combination Product
4NDC:84778-085-048 in 1 BOX08/24/2025
460 mg in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/24/2025
Labeler - Guangzhou Yixin Cross-border E-commerce Co., Ltd. (455800881)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Yixin Cross-border E-commerce Co., Ltd.455800881manufacture(84778-085) , label(84778-085)

Revised: 9/2025
Document Id: 3dcadf2b-8896-9183-e063-6394a90a27d2
Set id: 3d716ac1-7e1b-ce8a-e063-6394a90a52ab
Version: 4
Effective Time: 20250902
 
Guangzhou Yixin Cross-border E-commerce Co., Ltd.