PANAMA JACK BURN RELIEF GEL- lidocaine hydrochloride gel 
Prime Enterprises Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Panama Jack Burn Relief Gel with Aloe Vera and Lidocaine

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

Do not use

Stop use and contact a physician

Keep out of reach of children.

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

Directions

Other Information

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

PANAMA JACK  BURN RELIEF GEL
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0261
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS7.128 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0261-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/25/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/25/2018
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0261) , manufacture(58443-0261) , label(58443-0261) , analysis(58443-0261)

Revised: 1/2020
Document Id: 9c59ea17-cd8f-7ccb-e053-2995a90ada4c
Set id: 7055acd5-1c83-397e-e053-2a91aa0a3852
Version: 2
Effective Time: 20200117
 
Prime Enterprises Inc.