FDA Label for Prevasil Ultra Care Lip Balm

View Indications, Usage & Precautions

Prevasil Ultra Care Lip Balm Product Label

The following document was submitted to the FDA by the labeler of this product Bolm, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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




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