NYLOXIN Stage 3 Pain Relief: Homeopathic Product Information

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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Active Ingredients

Asian Cobra venom 140 mcg/mL

Purpose

* According to the Homeopathic Pharmacopeia of the United States

Analgesic *

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

Warnings:

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Side effects may include headache, nausea, sore throat, allergic rhinitis and gastrointestinal upset.

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If symptoms persist or worsen, stop using this product and consult a physician.

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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.

• 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.

Package Label — Principal Display Panel – 1.0 oz Spray Label

Package Label — Principal Display Panel – 1.0 oz Spray Carton

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 DEA Schedule

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

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID ANHYDROUS TRISODIUM CITRATE METHYLPARABEN XYLITOL 2-(DIETHYLAMINO)ETHANOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:47219-250-10 1 BOTTLE, SPRAY (BOTTLE) in 1 BOX contains a BOTTLE, SPRAY 1 30 mL in 1 BOTTLE, SPRAY This package is contained within the BOX (47219-250-10)

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	Operations
RECEPTOPHARM INC		145377888	ANALYSIS, MANUFACTURE, API MANUFACTURE

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

Revised: 11/2009 RECEPTOPHARM INC