Otc - Active Ingredient
Active ingredient PurposeCamphorated phenol (camphor 10.8% and phenoll 4.7%) .........................Pain reliever/antiseptic
Camphor (synthetic) And Phenol
FDA Label NDC 59779-088
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Camphor (synthetic) And Phenol (NDC 59779-088). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Active ingredient PurposeCamphorated phenol (camphor 10.8% and phenoll 4.7%) .........................Pain reliever/antisepticUse- for the temporary relief of pain and itching associated with cold sores and fever blisters- first aid to help prevent infection
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.Do not induce vomiting before contacting medical help or a Poison Control Center.
Indications & Usage
Uses- for the temporary relief of pain and itching associated with cold sores and fever blisters- first aid to help prevent infection
Warnings
Warnings For external use only. ______________________________________________________________________________Do not use - over large areas of the body - with a bandage______________________________________________________________________________Ask a doctor before use if you have- a deep puncture wound - animal bites - serious burns______________________________________________________________________________When using this product do not use in or near the eyes. If contact occurs rinse eyesthoroughly with water and obtain medical attention.______________________________________________________________________________Stop use and ask a doctor if - condition worsens -symptoms persist for more than 7 days or clear up and occur again within a few days______________________________________________________________________________Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.Do not induce vomiting before contacting medical help or a Poison Control Center
Dosage & Administration
Directions- adults and children two years and over: - clean the affected area- apply directly to teh cold sore or fever blister 1 to 3 times daily- Do not bandageChildren under two years: ask a doctor Other informationStore at room temperature. Avoid excessive heat.Close cover tightly after each use
Inactive Ingredient
Inactive Ingredients colloided silicon dioxide, eucalyptus oil, glycerin, light mineral oil
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