Label: PANAMA JACK BURN RELIEF GEL- lidocaine hydrochloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0261-4 - Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 17, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- When using this product
- Do not use
- Stop use and contact a physician
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
- Panama Jack Burn Relief Topical Analgesic Gel
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INGREDIENTS AND APPEARANCE
PANAMA JACK BURN RELIEF GEL
lidocaine hydrochloride gelProduct 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)