FDA.reportPublic FDA data

COLDSORE BOMB

Manufacturer
Envisionate PSJ LLC
Effective date
2019-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:26:32

Label at a glance#

ProductCOLDSORE BOMB
Active ingredientZINC OXIDE
Label structure10 sections

Dosage and administration

Adults and children 2 years of age and older: Apply to the affected area not more than 3-4 times daily Children under 2 years of age: Consult a doctor

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

Zinc Oxide (2.5mgs per 1g of product by input weight)

Purpose

OTC - PURPOSE SECTION

External analgesic

Use

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with fever blisters and cold sores

Warnings

WARNINGS SECTION

For external use only

Stop use and ask a doctor if Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

When using this product Avoid contact with the eyes

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 immediately (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to the affected area not more than 3-4 times daily
  • Children under 2 years of age: Consult a doctor

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lanolin, Cocoa Butter, Coconut Oil, Grapeseed Oil, Peppermint Oil, Tea Tree Oil, Croton Lechleri Sap (Dragons Blood)

Questions or Comments?

OTC - QUESTIONS SECTION

(801) 623-1595

M-F 9am-5pm or visit our website at ColdsoreBomb.com

SPL UNCLASSIFIED SECTION

"Explosive Cold Sore Relief"

100% ALL NATURAL

Distributed By: Envisionate PSJ Lehi UT 84043

NDC 72883-019-01

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ColdsoreColdsore

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72883-01972883-019-01

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
ZINC OXIDESOI2LOH54ZACTIM
LANOLIN7EV65EAW6HIACT
COCOA BUTTER512OYT1CRRIACT
COCONUT OILQ9L0O73W7LIACT
GRAPE SEED OIL930MLC8XGGIACT
PEPPERMINT OILAV092KU4JHIACT
TEA TREE OILVIF565UC2GIACT
CROTON LECHLERI RESINGGG6W25C63IACT

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
9502ff50-4bdd-4912-b376-17263537d23b4bf22314-d9c8-49ce-951f-28cfd189f3f22019-12-10WarningsExact identifier
spl set id: 4bf22314-d9c8-49ce-951f-28cfd189f3f2

Reported adverse events (FAERS/openFDA)#

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