FDA.reportPublic FDA data

COLDSORE BOMB

Manufacturer
Envisionate PSJ LLC | Paket Corporation
Effective date
2020-10-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:31:19

Label at a glance#

ProductCOLDSORE BOMB
Active ingredientMENTHOL
Label structure7 sections

Dosage and administration

Adults and children 2 years of age and older: Apply to the affected area not more than 5 times daily.

Storage and handling

Store at room temperature 68 to 77°F (20 to 25ºC).

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 1%

Purpose

OTC - PURPOSE SECTION

External analgesic

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to the affected area not more than 5 times daily.

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature 68 to 77°F (20 to 25ºC).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cocoa Butter, Coconut Oil, Croton Lechleri, Grapeseed Oil, Lanolin, Peppermint Oil, Tea Tree Oil

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mentholmenthol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
418610menthol 1 % Topical OintmentPSN2
418610menthol 0.01 MG/MG Topical OintmentSCD2
418610menthol 1 % Topical OintmentSY2
418610menthol 1 % Topical StickSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72883-020-012022-01-28C16284748780-1d6a99b39-caef-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72883-020-01COLDSORE BOMB1 in 1 BOXOINTMENT12
72883-020-01COLDSORE BOMB3.5 g in 1 TUBEOINTMENT3.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72883-020COLDSORE BOMB (MENTHOL) OINTMENT [ENVISIONATE PSJ LLC]2Legacy NDC, 2 package rows20201009_f5d5f4c6-fb92-402e-bc22-c4b80aeb51ea.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72883-02072883-020-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
LANOLIN7EV65EAW6HIACT
COCOA BUTTER512OYT1CRRIACT
COCONUT OILQ9L0O73W7LIACT
GRAPE SEED OIL930MLC8XGGIACT
PEPPERMINT OILAV092KU4JHIACT
CROTON LECHLERI RESINGGG6W25C63IACT
TEA TREE OILVIF565UC2GIACT

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
0d47f277-97c2-4dcd-9324-5cdb6f31412cf5d5f4c6-fb92-402e-bc22-c4b80aeb51ea2020-10-02Exact identifier
spl id: 0d47f277-97c2-4dcd-9324-5cdb6f31412c
spl set id: f5d5f4c6-fb92-402e-bc22-c4b80aeb51ea

Reported adverse events (FAERS/openFDA)#

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