KOPE PAIN RELIEF GEL- lidocaine gel 
CA-BOTANA INTERNATIONAL

----------

Kope Pain relief gel

OTC - ACTIVE INGREDIENT

Lidocaine 4% Topical Analgesic

Other Safety Information

Protect this product from excessive heat and direct sun

OTC - ASK DOCTOR

Stop use and ask a doctor if redness is present.irritation develops. conditions worsens or symtoms persist more than 7 days. symtoms clear up and occur again within a few days

OTC - PURPOSE SECTION

Uses: for temporary relief of pain

Keep out of reach of children

Keep out of reach of children

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.

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

Adult and children 12 years of age and older: Apply and massage 2 to 3 layersonto affected area upto 3 times a day. Children under 12 years of age: consult a doctor.

Indications & usage

Apply and massage 2 to 3 layers onto affected area up to 3 times a day

Package label princip[al panel

1  .jpg

KOPE PAIN RELIEF GEL 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-026
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
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
Coloryellow (Brownish-Yelow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35192-026-1050 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/30/2017
Labeler - CA-BOTANA INTERNATIONAL (106276728)
Establishment
NameAddressID/FEIBusiness Operations
CA-BOTANA INTERNATIONAL106276728manufacture(35192-026)

Revised: 10/2023
Document Id: 079ae211-51eb-6892-e063-6394a90a2aca
Set id: 52f64082-9065-10a9-e054-00144ff8d46c
Version: 17
Effective Time: 20231013
 
CA-BOTANA INTERNATIONAL