Label: KOPE PAIN RELIEF GEL- lidocaine gel
- NDC Code(s): 35192-026-10
- Packager: CA-BOTANA INTERNATIONAL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 13, 2023
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- Official Label (Printer Friendly)
- OTC - ACTIVE INGREDIENT
- Other Safety Information
- OTC - ASK DOCTOR
- OTC - PURPOSE SECTION
- Keep out of reach of children
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INACTIVE INGREDIENTS
CAPRYLYL GLYCOL, POLYOXYL 40 CASTOR OIL, ALOE VERA LEAF, ARNICA MONTANA, BUTYLENE GLYCOL, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, MELISSA OFFICINALIS, MENTHA PIPERITA, MENTHOL, PEG-40 HYDROGENATED CASTOR OIL, PHENOXYETHANOL, POTASSIUM SORBATE, PPG-26-BUTETH-26, ROSMARINUS OFFICINALIS, ROYAL YELLY, TRIDECETH-9, TROLAMINE SALYCYLATE, ALPHA-TOCOPHEROL ACETATE, WATER, XANTHAN GUM, 1,2 HEXANEDIOL, DI METHYL SULFUXIDE (MSM), PROPYLENE GLYCOL, EDETATE SODIUM TETRAHYDRATE, ALCOHOL, PHOSPHATYLCHOLINE.
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Warnings
For external use only, Avoid contact with eyes. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. If conditions worsens or symtoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product consult a doctor. Do not use in large quantities particularly over raw surfaces or blistered areas.
- Dosage & Admnistration
- Indications & usage
- Package label princip[al panel
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INGREDIENTS AND APPEARANCE
KOPE PAIN RELIEF GEL
lidocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35192-026 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 50 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W) EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) DIPALMITOYLPHOSPHATIDYLCHOLINE, DL- (UNII: 2W15RT5V7V) ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA (UNII: O80TY208ZW) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) MELISSA OFFICINALIS (UNII: YF70189L0N) MENTHA PIPERITA (UNII: 79M2M2UDA9) MENTHOL (UNII: L7T10EIP3A) PEG-4 HYDROGENATED CASTOR OIL (UNII: 43SW2U113W) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P) ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M) ROYAL JELLY (UNII: L497I37F0C) TRIDECETH-9 (UNII: X9HD79I514) TROLAMINE SALICYLATE (UNII: H8O4040BHD) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Product Characteristics Color yellow (Brownish-Yelow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35192-026-10 50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 06/30/2017 Labeler - CA-BOTANA INTERNATIONAL (106276728) Establishment Name Address ID/FEI Business Operations CA-BOTANA INTERNATIONAL 106276728 manufacture(35192-026)
