FDA.reportPublic FDA data

Prevasil ULTRA CARE LIP BALM

Manufacturer
Bolm, Inc. | Raining Rose, Inc.
Effective date
2019-04-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:23

Label at a glance#

ProductPrevasil ULTRA CARE LIP BALM
Active ingredientCAMPHOR (SYNTHETIC), THYMOL
Label structure11 sections

Indications and uses

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

Dosage and administration

• 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 unti...

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

Camphor- 3.10% Thymol 0.13%

Purpose

OTC - PURPOSE SECTION

External Analgesic

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

• 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

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

• 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

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) *CERTIFIED ORGANIC

Product Label 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelcartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2166926camphor 3.1 % / thymol 0.13 % Topical OintmentPSN1
2166926camphor 0.031 MG/MG / thymol 0.0013 MG/MG Topical OintmentSCD1
2166926camphor 3.1 % / thymol 0.13 % Topical OintmentSY1
2166926camphor 3.1 % / thymol 0.13 % Topical StickSY1

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
72456-002-012021-01-29C16284748780-1ba0f9c33-3a74-a910-e053-dadaa90a0b8562836349-d1ac-4a1b-a09b-f1841da1c521

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72456-002-01Prevasil ULTRA CARE LIP BALM4.25 g in 1 TUBESTICK4.251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72456-002PREVASIL ULTRA CARE LIP BALM (CAMPHOR,THYMOL) STICK [BOLM, INC.]1Legacy NDC, 1 package rows20190501_62836349-d1ac-4a1b-a09b-f1841da1c521.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
72456-00272456-002-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
THYMOL3J50XA376EACTIB
CHAMOMILEFGL3685T2XIACT
ACHILLEA MILLEFOLIUM OIL97P5D0WG43IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CANDELILLA WAXWL0328HX19IACT
COCONUT OILQ9L0O73W7LIACT
FRANKINCENSE OIL67ZYA5T02KIACT
HELICHRYSUM ITALICUM FLOWER OILO97ZV7726KIACT
JOJOBA OIL724GKU717MIACT
BACKHOUSIA CITRIODORA LEAF OIL2UQQ0PI06PIACT
LEMON OILI9GRO824LLIACT
EAST INDIAN LEMONGRASS OILUP0M8M3VZWIACT
LYSINE HYDROCHLORIDEJNJ23Q2COMIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
MELISSA OFFICINALIS LEAF OILPTP6R7263MIACT
PEPPERMINT OILAV092KU4JHIACT
POMEGRANATE SEED OIL0UI45XV0T6IACT
RASPBERRY SEED OIL9S8867952AIACT
ROSA MOSCHATA OILJ99W255AWFIACT
ROSEMARYIJ67X351P9IACT
SAGE OILU27K0H1H2OIACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT
SHEA BUTTERK49155WL9YIACT
SUNFLOWER OIL3W1JG795YIIACT
THYME OIL2UK410MY6BIACT
TOCOPHEROLR0ZB2556P8IACT

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
0871fb89-ffe5-41b7-aa94-564837e8602762836349-d1ac-4a1b-a09b-f1841da1c5212019-04-12WarningsExact identifier
spl id: 0871fb89-ffe5-41b7-aa94-564837e86027
spl set id: 62836349-d1ac-4a1b-a09b-f1841da1c521

Reported adverse events (FAERS/openFDA)#

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