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Kope pain relief gel - Medication Information

Product NDC Code 35192-026
Drug Name

Kope pain relief gel

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine 4 g/50g
Route TOPICAL
Dosage Form GEL
Application Number M017
Labeler Name CA-BOTANA INTERNATIONAL
Packages
Package NDC Code Description
35192-026-10 50 g in 1 bottle, pump (35192-026-10)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
OTC - ACTIVE INGREDIENT Lidocaine 4% Topical Analgesic

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Indications & usage Apply and massage 2 to 3 layers onto affected area up to 3 times a day

Purpose

Information about the drug product’s indications for use.
OTC - PURPOSE SECTION Uses: for temporary relief of pain

Spl product data elements

Usually a list of ingredients in a drug product.
Kope Pain relief gel Lidocaine 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 LIDOCAINE LIDOCAINE 1,2-HEXANEDIOL PROPYLENE GLYCOL CAPRYLYL GLYCOL Brownish-Yelow

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package label princip[al panel 1 .jpg

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
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

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children Keep out of reach of children

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other Safety Information Protect this product from excessive heat and direct sun

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API