Drug Facts & Ingredients
Official FDA Drug Label
Drug Facts &
Ingredients.
Coldsore Bomb is a registered OTC drug product — not just a lip balm. Here's exactly what's in it and why it works.
Menthol 1% Active
All Natural Formula
FDA OTC Monograph
Topical Ointment
Official Label
Drug Facts
The full, official Drug Facts panel as registered with the FDA and published on DailyMed.
Drug Facts
Net Wt. 3.5 g
Active Ingredient (in each gram)
Menthol 1%
External Analgesic
Uses
For temporary relief of pain and itching associated with cold sores and fever blisters.
⚠️
Warnings — For external use only.
Avoid contact with eyes. If condition worsens or symptoms persist more than 7 days, or clear up and recur, stop use and consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults & children 2+
Apply to affected area not more than 5 times daily
Children under 2
Ask a doctor
Other Information
Storage
Store at room temperature: 68–77°F (20–25°C)
Inactive Ingredients
Cocoa Butter, Coconut Oil, Croton Lechleri (Dragon's Blood), Grapeseed Oil, Lanolin, Peppermint Oil, Tea Tree Oil
Distributed by Envisionate PSJ LLC · NDC 72883-020-01
View on DailyMed ↗
What's Inside
Every Ingredient, Explained.
One FDA-recognized active. Seven botanicals that work alongside it.
Active Ingredient
Menthol 1%
UNII: L7T10EIP3A · 1 g per 100 g
FDA-recognized external analgesic. Provides temporary pain and itch relief directly at the cold sore site.
Inactive
Dragon's Blood
Croton Lechleri · UNII: GGG6W25C63
Our key differentiator. Amazonian tree resin with 2,000+ years of use and 365+ published studies behind it.
Inactive
Cocoa Butter
UNII: 512OYT1CRR
Rich emollient base that prevents the formula from drying out already-sensitive skin.
Inactive
Coconut Oil
UNII: Q9L0O73W7L
Lightweight carrier oil. Helps active ingredients absorb while keeping the formula smooth.
Inactive
Grapeseed Oil
UNII: 930MLC8XGG
Fast-absorbing oil that adds slip without clogging pores.
Inactive
Lanolin
UNII: 7EV65EAW6H
Natural wax that forms a protective barrier to lock in moisture and shield the sore.
Inactive
Peppermint Oil
UNII: AV092KU4JH
Amplifies the cooling sensation and gives Coldsore Bomb its signature fresh scent.
Inactive
Tea Tree Oil
UNII: VIF565UC2G
Widely used in natural topical preparations for skin clarity and wellness.
How to Use
Directions.
👥
Who Can Use It
Adults & Children 2+
Safe for adults and children 2 years and older. Children under 2: ask a doctor first.
✋
Application
Up to 5× Daily
Apply a small amount directly to the affected area. No more than five times per day.
📅
When to Stop
The 7-Day Rule
If symptoms don't clear up within 7 days — or come back — stop use and see a doctor.
🌡️
Storage
Room Temperature
Store between 68–77°F. Keep the cap on when not in use.
Regulatory Information
FDA Registration & Identifiers.
Official registration details from the U.S. National Library of Medicine DailyMed database.
| Field | Value |
|---|---|
| Product Name | COLDSORE BOMB — Menthol 1% Topical Ointment |
| Product Type | Human OTC Drug |
| Marketing Status | OTC Monograph Final |
| Monograph Citation | 21 CFR Part 346 (External Analgesics) |
| NDC Code | 72883-020-01 |
| Route | Topical |
| Labeler / Registrant | Envisionate PSJ LLC (FEI: 116959523) |
| Manufacturer | Paket Corporation (FEI: 007774730) |
| Package Size | 3.5 g tube in 1 box |
| Marketing Start | December 9, 2019 |
| Label Last Updated | October 2, 2020 |
| DailyMed Set ID | f5d5f4c6-fb92-402e-bc22-c4b80aeb51ea ↗ |
| RxCUI | 418610 |
| DEA Schedule | None |
⚠️ FDA Disclaimer
Most OTC drugs are not reviewed and approved by the FDA; however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. This page is derived from the official DailyMed label and is for informational purposes only. Not intended to diagnose, treat, cure, or prevent any disease.
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