Label: PANAMA JACK BURN RELIEF GEL WITH LIDOCAINE- lidocaine hydrochloride gel
- NDC Code(s): 58443-0648-4
- Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 2, 2024
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- INACTIVE INGREDIENT
- Panama Jack Burn Relief with Lidocaine
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INGREDIENTS AND APPEARANCE
PANAMA JACK BURN RELIEF GEL WITH LIDOCAINE
lidocaine hydrochloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0648 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 7.13 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) EDETATE DISODIUM (UNII: 7FLD91C86K) MENTHOL (UNII: L7T10EIP3A) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM HYDROXIDE (UNII: 55X04QC32I) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0648-4 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/19/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 10/19/2015 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0648) , manufacture(58443-0648) , label(58443-0648) , analysis(58443-0648)