Active Ingredients
Tetracaine 2%
Mineral oil 74.4%
Helocaine Cold Sore Fever Blister Treatment Ointment
FDA Label NDC 83609-212
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pagari Life Science Corp. for the product Helocaine Cold Sore Fever Blister Treatment (NDC 83609-212). 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, do not use, when using this product, stop use and ask a doctor if, 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
Topical analgesic
Skin protectant
Uses
- for the temporary relief of pain and itching associated with fever blisters and cold sores
- helps prevent and temporarily protects chapped or cracked lips
- helps prevent and protect from the drying effects of wind and cold weather
Warnings
For external use only.
Do Not Use
- on • deep or puncture wounds • animal bites • serious burns
- in large quantities, particularly over raw surfaces or blistered areas
When Using This Product
- do not get into eyes
Stop Use And Ask A Doctor If
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
- allergic reaction (blister or rash worsens) to any of the ingredients
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center
Directions
Adults and children 2 years of age and older
- apply to affected area not more than 3 to 4 times daily
- consult a doctor
Children under the age of 2
Other Information
- store at 20° - 25° C (68° - 77° F)
Inactive Ingredients
peppermint oil, polyethylene, polyethylene oxide, polyethylene glycol, sodium carboxymethylcellulose
Questions Or Comments?
call 1- (877) 513-3057 (toll-free)
Package Labeling
Label (Label)
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