Prevasil Ultra Care Lip Balm
FDA Label NDC 72456-002

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 Ultra Care Lip Balm (NDC 72456-002). 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

Camphor- 3.10% Thymol 0.13%

Purpose

External Analgesic

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

• helps treat and provide temporary relief from symptoms of cold sores/fever blisters
• temporarily protects and helps relieve chapped or cracked lips

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

• for cracking or dryness, continue to cover lips until absorbed
• use daily on the lips as needed during periods of high stress, sickness or fatigue, or apply liberally to the affected area within the first hour of an emerging cold sore
• rub in gently but completely
• for cold sores/fever blisters, reapply liberally as the cooling effect wears off and continue reapplying throughout the following 8 hours, or until symptoms subside

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) *CERTIFIED ORGANIC

Questions Or Comments?

Contact us at www.prevasil.com

Product Label

Label (Pervasil)

Label (Pervasil)

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