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Kope Pain relief gel by CA-BOTANA INTERNATIONAL

Medically reviewed on Oct 31, 2017

Dosage form: gel
Ingredients: LIDOCAINE 4g in 50g
Labeler: CA-BOTANA INTERNATIONAL
NDC Code: 35192-027

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.

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 principal panel

KOPE PAIN RELIEF GEL 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-027
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE4 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
.ALPHA.-GLUCAN OLIGOSACCHARIDE 
EDETATE SODIUM TETRAHYDRATE 
DIMETHYL SULFONE 
DIPALMITOYLPHOSPHATIDYLCHOLINE, DL- 
ALOE VERA LEAF 
ARNICA MONTANA 
BUTYLENE GLYCOL 
ETHYLHEXYLGLYCERIN 
HEXYLENE GLYCOL 
MELISSA OFFICINALIS 
MENTHA PIPERITA 
MENTHOL 
PEG-4 HYDROGENATED CASTOR OIL 
PHENOXYETHANOL 
POTASSIUM SORBATE 
PPG-26-BUTETH-26 
ROSMARINUS OFFICINALIS WHOLE 
ROYAL JELLY 
TRIDECETH-9 
TROLAMINE SALICYLATE 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
XANTHAN GUM 
1,2-HEXANEDIOL 
PROPYLENE GLYCOL 
CAPRYLYL GLYCOL 
Product Characteristics
Coloryellow (Brownish-Yelow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:35192-027-115 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/15/2017
Labeler - CA-BOTANA INTERNATIONAL (106276728)
Establishment
NameAddressID/FEIOperations
CA-BOTANA INTERNATIONAL106276728manufacture(35192-027)

 
CA-BOTANA INTERNATIONAL

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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