Active Ingredients
Lidocaine Hydrochloride (0.72%)
Panama Jack
FDA Label NDC 58443-0261
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises Inc. for the product Panama Jack (NDC 58443-0261). 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, otc - do not use, otc - when using, otc - ask doctor, otc - 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
Uses
For the temporary relief of pain associated with sunburn, insect bites and minor skin irritations.
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove
Otc - Ask Doctor
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
When Using This Product
- Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
Do Not Use
- in large quantities, particularly over raw surfaces or blistered areas.
Stop Use And Contact A Physician
- If irritation occures.
- If condition worsens, or if 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 immediately.
Directions
- Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
- Children under 2 years of age: ask a doctor
Other Information
- Protect from heat.
- Store at controlled room temperature.
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Blue 1, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Menthol, Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol 40-B, Sodium Hydroxide, Yellow 5, Water
Panama Jack Burn Relief Topical Analgesic Gel
Principal Display Label (58443 0261 4)
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