Otc - Purpose
External analgesic
Blister Balm
FDA Label NDC 70996-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Floratech Botanicals, Llc for the product Blister Balm (NDC 70996-003). 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 - purpose, otc - active ingredient, purpose, uses:, warnings, keep out of reach of children., otc - keep out of reach of children, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients
Menthol 1%
Purpose
External Analgesic - cold sore or fever blister treatment
Uses:
For relief of pain and itching associated with cold sore and fever blister outbreaks.
Intense and immediate blocking of cold sore and gever blister symptoms.
Warnings
For external use only.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
keep out of reach of children. If swallowed get medical help or contact a poison control center immediately. (1-800-222-1222)
Otc - Stop Use
Stop use and ask doctor if condition worsen or if symptoms persist for more than 7 days or clear up and occur again within a few days.
When using this product avoid contact with the eyes
keep out of Reach of children. If swallowed, get medical help or contact a poison control center immediately. (1-800-222-1222)
Directions
- Adults and children 2 years of age and older. Apply to the afftected area not more than 3 to 4 times daily.
- Children under 2 years of age: consult a doctor
Inactive Ingredients
camphor
clove (syzygium aromaticum) leaf oil
eucalyptus globulus leaf oil
hydrolyzed jojoba esters
isopropyl jojobate
jojoba (simmondsia chinensis) esters
jojoba alcohols
lemon balm (melissa officinalis) oil
peppermint (menthe piperita) oil
rose geranium (pelargonium graveolens) oil
* Please review the disclaimer below.
