KOPE PAIN RELIEF GEL- lidocaine gel

Kope Pain relief gel by

Drug Labeling and Warnings

Kope Pain relief gel by is a Otc medication manufactured, distributed, or labeled by CA-BOTANA INTERNATIONAL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

KOPE PAIN RELIEF GEL 
lidocaine gel

Product 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 not final	part348	06/30/2017

Labeler - CA-BOTANA INTERNATIONAL (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-BOTANA INTERNATIONAL		106276728	manufacture(35192-026)