NYLOXIN STAGE 3 PAIN RELIEF- naja naja venom spray, metered

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 140 mcg/mL

Purpose

* According to the Homeopathic Pharmacopeia of the United States

Analgesic*

INDICATIONS & USAGE

Uses: Temporarily relieves pain associated with sore back, inflamed joints, migraines, painful menses, and general presistent pain

Warnings:

• - Side effects may include headache, nausea, sore throat, allergic rhinitis and gastrointestinal upset.
• - If symptoms persist or worsen, stop using this product and consult a physician.
• - When Using This Product: avoid contact with the eyes. If product gets into eyes, flush with water. Seek medical attention.

Directions For Use:

• Break off protective tab.
• Turn press lock so spray nozzle is visible in front.
• Press down 4 x to prime the pump.
• Spray 2 x directly into mouth or under tongue.
• Use spray intially every 3-4 hours.

Other Information:

• Do not use if tamper-proof seal is broken.
• This product is NOT intended to treat disease, it can provide a temporary level of comfort, relief and a feeling of wellness.
• This product has been determined to be safe and effective for moderate to severe (Stage 2) pain.
• Clinical experience suggests Nyloxin may provide relief from other forms of pain.

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients:

Citric Acid, Ethanol, Flavoring, Methylparaben, Sodium Citrate, Xylitol.

PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel – 1.0 oz Spray Label

PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel – 1.0 oz Spray Carton

INGREDIENTS AND APPEARANCE

NYLOXIN  STAGE 3 PAIN RELIEF
naja naja venom spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47219-250
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM)	NAJA NAJA VENOM	140 ug  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
METHYLPARABEN (UNII: A2I8C7HI9T)
XYLITOL (UNII: VCQ006KQ1E)
2-(DIETHYLAMINO)ETHANOL (UNII: S6DL4M053U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47219-250-10	1 in 1 BOX
1		30 mL in 1 BOTTLE, SPRAY

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