Active Ingredient
Camphor 10.8%, Phenol 4.7%
Chapice Camphor Phenol Gel
FDA Label NDC 63645-160
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oralabs for the product Chapice Camphor Phenol Gel (NDC 63645-160). 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 ingredient, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately. Do not induce vomiting before contacting medical help or a Poison Control Center. For adults and children over 2 years of age.
Uses
For the temporary relief of pain and itching associated with cold sores and fever blisters. First Aid to help prevent infection.
Warnings
For external use only.
Do not use over large areas of the body or with a bandage. Ask a doctor before use if you have a deep puncture wound, animal bites, or serious burns.
When using this product: avoid contact with eyes. Rinse with water to remove. Seek medical help or contact a Poison Control Center.
Stop use and consult a doctor if: conditions worsen or last more than 7 days, or if it clears up and returns again in a few days.
Directions
Adults and children over 2 years clean the affected area and apply directly to a cold sore or fever blister 1 to 3 times daily. Do not bandage.
Inactive Ingredients
Colloidal Silicon Dioxide, Eucalyptus Oil, Glycerin, Light Mineral Oil
* Please review the disclaimer below.
