PANAMA JACK BURN RELIEF GEL WITH LIDOCAINE- lidocaine 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 with 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.

For external use only.

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 occurs.
  • 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

Other Information

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

Questions or Comments?

Email us at info@panamajack.com or call 1-800-840-5225

Panama Jack Burn Relief with Lidocaine

Principal Display Panel

PANAMA JACK  BURN RELIEF GEL WITH LIDOCAINE
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS7.13 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SULISOBENZONE (UNII: 1W6L629B4K)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0204-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/19/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34610/19/2015
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0204) , manufacture(58443-0204) , label(58443-0204)

Revised: 1/2020
Document Id: 9c59ee9e-98ae-988f-e053-2995a90a5cc6
Set id: 25eedcb5-f40a-2e9b-e054-00144ff8d46c
Version: 3
Effective Time: 20200117
 
Prime Enterprises Inc.