FDA Label for Carmex Multi-symptom 3 In 1 Cold Sore Treatment External Analgesic Skin Protectant
View Indications, Usage & Precautions
Carmex Multi-symptom 3 In 1 Cold Sore Treatment External Analgesic Skin Protectant Product Label
The following document was submitted to the FDA by the labeler of this product Carma Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Benzocaine 10%
White Petrolatum 44.69%
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:
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