Panama Jack Burn Relief With Lidocaine
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Panama Jack
FDA Label NDC 58443-0204
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 58443-0204). 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 panama jack burn relief with lidocaine, active ingredients, purpose, uses, warnings, otc - when using, otc - do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Lidocaine Hydrochloride (0.72%)
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 - When Using
When using this product
- Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
Otc - Do Not Use
Do not use
- in large quantities, particularly over raw surfaces or blistered areas.
Otc - Ask Doctor
Stop use and contact a physician
- If irritation occurs.
- If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
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.
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 Ingredient
Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, DMDM Hydantoin, Fragrance, Menthol, Methylparaben, Polysorbate 20, Propylene Glycol, SD Alcohol 40-B, Triethanolamine, Water, Yellow 5
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