Prevasil
FDA Label NDC 72456-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bolm, Inc. for the product Prevasil (NDC 72456-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, warnings, uses, stop use and ask a doctor, keep out of reach of children, directions, storage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Synthetic camphor- 3.10%

Thymol crystals 0.13%

Purpose

External Anagesic

Warnings

For external use only
Do not use if you are allergic or sensitive to any ingredient in this product
When using this product
• apply only to the affected areas
• do not use in or near the eyes

• avoid applying directly inside the mouth

• do not share this product with anyone, as this may spread infection

Uses

Relieves Pain
Anti-Itch
Soothes Instantly
Promotes Healing
for temporary relief of pain and itching associated with cold sores and fever blisters

Stop Use And Ask A Doctor

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison
Control Center right away. CHOKING HAZARD. Has removable cap.

Directions

Directions
Adults and children 12 years and over:
• apply liberally to the affected area in the first hour of a cold sore or fever blister
• rub in gently but completely
• reapply often or as needed
• can also be applied during periods of remission

Storage

  • Keep away from heat. Do not freeze. Store at room temperature 20o-25oC (68o-77oF)

Inactive Ingredients

*Blue Chamomile Extract, *Blue Yarrow Oil, Calendula Extract, Candelilla Wax,

*Coconut Oil, *Frankincense Oil, *Helichrysum Oil, *Jojoba Oil, Lemon Myrtle Oil,

*Lemon Oil, *Lemongrass Oil, Lysine HCl, *Mango Butter, *Melissa (Lemon balm)

Oil, *Peppermint Oil, *Pomegranate Oil, Raspberry Seed Oil, *Rosehip Oil,

*Rosemary Leaf Extract, *Sage Oil, *Sea Buckthorn Oil, *Shea Butter, *Sunflower

Seed Oil, Thyme Oil, Tocopherol (Non-GMO)       

*Denotes Organic Ingredients 

Questions Or Comments?

Contact us at www.prevasil.com

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