Maximum Strength Cold Sore Treatment
- Manufacturer
- Ranir LLC | Accupack Midwest
- Effective date
- 2019-06-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:20:07
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients Purpose
Camphor 3.00%
Menthol 1.00%
Phenol 1.50%
White Petrolatum 89.20%
OTC - PURPOSE SECTION
Purpose
Cold sore/fever blister treatment
Cold sore/fever blister treatment
Cold sore/fever blister treatment
Skin Protectant
OTC - WHEN USING SECTION
Uses
• For treatment of cold sores/fever blisters on the face or lips
• Temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters
• Temporarily protects minor cuts, scrapes, burns, and sores
• Helps prevent and temporarily protects chapped or cracked skin and lips
WARNINGS SECTION
Warnings
For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or
puncture wounds, animal bites or serious burns, consult a physician.
Allergy alert: Do not use if you are allergic to any of the ingredients in this product.
When using this product avoid contact with eyes. Use only as directed.
Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless
directed by a doctor.
OTHER SAFETY INFORMATION
Other information store at room temperature
INACTIVE INGREDIENT SECTION
Inactive ingredients Eucalyptol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thymol,
Tocopheryl Nicotinate
OTC - QUESTIONS SECTION
Questions or comments?
Call us toll-free at 1-877-242-3234 Monday-Friday, 9 a.m. to 5 p.m. EST.
Serious side effects associated with use of this product may be reported to this number.
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
at 1-800-222-1222.
INDICATIONS & USAGE SECTION
Directions
• Clean the affected area • Apply a small amount of this product to the affected area 1 to 3 times daily
• Rub in gently • May be covered with a sterile bandage • Wash hands before and after applying cream
• Do not share this product with anyone • Children under 12 years of age: ask a doctor
RECENT MAJOR CHANGES SECTION
Indications and Usage
Section added 06/26/2019
Dosage and Administration
Section added 06/26/2019
DOSAGE & ADMINISTRATION SECTION
Apply a small amount of this product to the affected area 1 to 3 times daily
Cold Sore Tube card PDP
Maximum Strength
(Camphor 3.00%, Menthol 1.00%, Phenol 1.50%, White Petrolatum 89.20%)
Cold Sore Treatment
Temporary Relief of Pain and Discomfort!
- Works on Contact
- Applied Clear
Phalate Free**
Sulfate Free
Paraben Free*
With Tea Tree Oil
Medicated
Cold Sore / Fever Blister treatment & Skin Protectant
NET WT 0.07 OZ ( 2.0 g)
*Free from Methylparaben, Ethylparaben, Propylparaben and Butylparaben
** Tested per CPSC-CH-C1001.09.3
Distributed by:
Ranir LLC
4701 East Paris Ave SE
Grand Rapids, MI 49512
Products#
Every source-derived product name is available through these pages.
- Maximum Strength Cold Sore Treatment
- MENTHOL
- PETROLATUM
- TOCOPHERYL NICOTINATE, D-.ALPHA.
- TOCOPHEROL
- CAMPHOR (SYNTHETIC)
- PHENOL
- THYMOL
- EUCALYPTOL
- MELALEUCA ALTERNIFOLIA LEAF
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66923-412 | 66923-412-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| PETROLATUM | 4T6H12BN9U | ACTIB |
| TOCOPHERYL NICOTINATE, D-.ALPHA. | WI1J5UCY5C | IACT |
| CAMPHOR (SYNTHETIC) | 5TJD82A1ET | ACTIB |
| PHENOL | 339NCG44TV | ACTIB |
| THYMOL | 3J50XA376E | IACT |
| EUCALYPTOL | RV6J6604TK | IACT |
| MELALEUCA ALTERNIFOLIA LEAF | G43C57162K | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 96c4a20b-d73b-e1fc-e053-2a95a90a6e95 | 87edba6c-39e3-6568-e053-2a95a90a5688 | 2019-11-07 | Warnings | 87edba6c-39e3-6568-e053-2a95a90a5688 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
