Prevasil

Manufacturer
Bolm, Inc. | Raining Rose, Inc.
Effective date
2018-07-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:27

Label at a glance#

ProductPrevasil
Active ingredientCAMPHOR (SYNTHETIC), THYMOL
Label structure11 sections

Indications and uses

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

Dosage and administration

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 and handling

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

Label contents#

Full prescribing information#

Active ingredients  

OTC - ACTIVE INGREDIENT SECTION

Synthetic camphor- 3.10%

Thymol crystals 0.13%

Purpose

OTC - PURPOSE SECTION

External Anagesic

Warnings

WARNINGS SECTION

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

INDICATIONS & USAGE SECTION

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

OTC - ASK DOCTOR SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients 

INACTIVE INGREDIENT SECTION

*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 

Product Label 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product labelproduct label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2049992camphor 3.1 % / thymol 1.3 % Topical GelPSN1
2049992camphor 0.031 MG/MG / thymol 0.013 MG/MG Topical GelSCD1
2049992camphor 3.1 % / thymol 1.3 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72456-001-012021-01-29C16284748780-1ba0f9c33-1949-a910-e053-dadaa90a0b85fe8d4af7-0f47-4ee2-a038-58920fd0bab9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72456-001-01Prevasil4.25 g in 1 TUBEGEL4.251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72456-001PREVASIL (SYNTHETIC CAMPHOR,THYMOL) GEL [BOLM, INC.]1Legacy NDC, 1 package rows20180726_fe8d4af7-0f47-4ee2-a038-58920fd0bab9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72456-00172456-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d4db44f9-0fc5-431f-aed6-c4899682b39efe8d4af7-0f47-4ee2-a038-58920fd0bab92018-07-05WarningsExact identifier
spl id: d4db44f9-0fc5-431f-aed6-c4899682b39e
spl set id: fe8d4af7-0f47-4ee2-a038-58920fd0bab9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.