Active Ingredients
Benzocaine 10%
White Petrolatum 44.69%
Carmex Multi-symptom 3 In 1 Cold Sore Treatment External Analgesic Skin Protectant Cream
FDA Label NDC 10210-0048
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Carma Laboratories, Inc. for the product Carmex Multi-symptom 3 In 1 Cold Sore Treatment External Analgesic Skin Protectant (NDC 10210-0048). 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, stop use and ask a doctor or dentist if, do not use on, when using this product, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Skin Protectant
Uses
• For temporary relief of pain and itching associated with symptoms of fever blisters and cold sores
• Helps prevent and protect dry, chapped lips
Warnings
For external use only
Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetic
Stop Use And Ask A Doctor Or Dentist If
• cold sore symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens • swelling, rash, or fever develops
Do Not Use On
• deep or puncture wounds • animal bites • serious burns
When Using This Product
keep out of eyes. Rinse with water to remove. Do not exceed recommended dosage.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Using clean, dry hands apply 1 to 2 small dollops of Carmex Cold Sore product to the tip of the finger and gently apply and spread evenly to the surface of the cold sore to ensure even coverage over areas of redness. Wash hands thoroughly after application.
| Adults and children 2 years of age and older | Apply to affected area (lips) not more than 3 to 4 times daily |
| Children 2-12 years of age | Should be supervised in use of this product |
| Children under 2 years of age | Ask a doctor |
Other Information
• Protect this product from excessive heat and direct sunlight
• Store between 0° C to 28° C (32° F to 82.4° F)
Inactive Ingredients:
Polyethylene Glycol, HDI/Trimethylol Hexyllactone Crosspolymer, Titanium Dioxide, Behenyl Olivate, PPG-51 SMDI Copolymer, Mica, Synthetic Wax, Calcium Silicate, Flavor, Isopropyl Titanium Triisostearate, Silica, Tin Oxide, Iron Oxides (C.I 77491, C.I 77492, C.I. 77499)
Package Labeling:
Label4 (Label4)
Label5 (Label5)
* Please review the disclaimer below.
