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#

ProductMaximum Strength Cold Sore Treatment
Active ingredientMENTHOL, PETROLATUM, CAMPHOR (SYNTHETIC), PHENOL
Label structure12 sections

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PDPPDP

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66923-41266923-412-02

Ingredients#

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

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

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
96c4a20b-d73b-e1fc-e053-2a95a90a6e9587edba6c-39e3-6568-e053-2a95a90a56882019-11-07WarningsExact identifier
spl set id: 87edba6c-39e3-6568-e053-2a95a90a5688

Reported adverse events (FAERS/openFDA)#

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