FDA.reportPublic FDA data

Panama Jack

Manufacturer
Prime Enterprises Inc.
Effective date
2024-05-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:03:46

Label at a glance#

ProductPanama Jack Burn Relief Gel with Lidocaine
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For the temporary relief of pain associated with sunburn, insect bites, and minor skin irritations.

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride (0.72%)

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain associated with sunburn, insect bites, and minor skin irritations.

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

  • Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

OTC - DO NOT USE SECTION

Do not use

  • in large quantities, particularly over raw surfaces or blistered areas.

OTC - ASK DOCTOR SECTION

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 SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

  • Protect from heat,
  • Store at controlled room temperature.

INACTIVE INGREDIENT SECTION

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 with Lidocaine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display FrontPrincipal Display FrontPrincipal Display BackPrincipal Display Back

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-064858443-0648-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
EDETATE DISODIUM7FLD91C86KIACT
MENTHOLL7T10EIP3AIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
177dc94a-d3ab-f6cb-e063-6394a90a46bc177db16e-c3e1-dced-e063-6394a90a91fc2024-05-02WarningsExact identifier
spl id: 177dc94a-d3ab-f6cb-e063-6394a90a46bc
spl set id: 177db16e-c3e1-dced-e063-6394a90a91fc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.