Maximum Strength Cold Sore Treatment Gel
FDA Label NDC 41250-411

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc for the product Maximum Strength Cold Sore Treatment (NDC 41250-411). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, when using this product, stop use and consult a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Camphor 3.00%

Menthol 1.00%

Phenol 1.50%

White Petrolatum 89.20%

Purpose

Cold sore/fever blister treatment

Skin Protectant

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

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.

Allery 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.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

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

Other Information

store at room temperature

Inactive Ingredients

Eucalyptol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thymol, Tocopheryl Nicotinate

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.

Principal Display Panel

MAXIMUM STRENGTH

(Camphor 3.00%, Menthol 1.00%, Phenol 1.5%, White Petrolatum 89.20%)

cold sore treatment

Medicated

Temporary Relief of Pain and Discomfort

Works on Contact

Applies Clear

Phthalate Free

Paraben Free

Sulfate Free

With Tea Tree Oil

Cold Sore / Fever Blister Treatment & Skin Protectant

NET WT 0.07 oz (2.0 g)

Cold-sore-treatment (Image 01)

Cold-sore-treatment (Image 01)

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