PANAMA JACK BURN RELIEF GEL- lidocaine hydrochloride gel

Panama Jack by

Drug Labeling and Warnings

Panama Jack by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if rash occurs

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

INGREDIENTS AND APPEARANCE

PANAMA JACK  BURN RELIEF GEL
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0261
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	7.128 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MENTHOL (UNII: L7T10EIP3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALCOHOL (UNII: 3K9958V90M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0261-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/25/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/25/2018

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0261) , manufacture(58443-0261) , label(58443-0261) , analysis(58443-0261)