NYLOXIN STAGE 3 PAIN RELIEF- naja naja venom gel

NYLOXIN by

Drug Labeling and Warnings

NYLOXIN by is a Homeopathic medication manufactured, distributed, or labeled by RECEPTOPHARM INC, LIQUID PACKAGING RESOURCES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Asian Cobra venom 60 mcg/mL

Purpose

* According to the Homeopathic Pharmacopeia of the United States

Analgesic*

INDICATIONS & USAGE

Uses: Temporarily relieves joint pain associated with overuse and pain associated with arthritis.

Warnings:

• - For external use only
• - If symptoms persist or worsen, discontinue use and seek medical attention.
• - Avoid contact with eyes. If product gets into eyes, flush with water. Seek Medical attention.
• - Not for use on open wounds.

Directions For Use:

• Remove protective wrapping.
• Liberally apply gel to the affected area and rub into joints.
• Use 3-4 times per day for the first week. Use as needed thereafter to relieve discomfort.
• Allow several days for drug to take maximum effect.

Other Information:

• Do not use if container seal is broken prior to opening.
• This product is intended for use in cases of recurring joint pain.
• This product is NOT intended to treat disease. It provides a temporary level of comfort, relief, and a feeling of wellness.
• This product has been determined to be safe and effective for mild to moderate (Stage 2) chronic pain, as indicated by the Homeopathic Pharmacopeia of the United States.

SPL UNCLASSIFIED SECTION

• Pregnant or nursing women and children should not use this product unless advised by a physician.

Inactive Ingredients:

Benzalkonium chloride, Ethanol, Methocel, Propylene glycol, Saline

PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel – 2.0 oz Gel Label

PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel – 2.0 oz Gel Carton

INGREDIENTS AND APPEARANCE

NYLOXIN  STAGE 3 PAIN RELIEF
naja naja venom gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47219-253
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM)	NAJA NAJA VENOM	60 ug  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
2-(DIETHYLAMINO)ETHANOL (UNII: S6DL4M053U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47219-253-20	1 in 1 BOX
1		60 mL in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		08/25/2009

Labeler - RECEPTOPHARM INC (145377888)

Establishment
Name	Address	ID/FEI	Business Operations
RECEPTOPHARM INC		145377888	ANALYSIS, MANUFACTURE, API MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
LIQUID PACKAGING RESOURCES		018935165	MANUFACTURE