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:

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.
  • 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

1.0 oz Spray Bottle Label
(click image for full-size original)

Package Label — Principal Display Panel – 1.0 oz Spray Carton

1.0 oz Spray Bottle Carton
(click image for full-size original)
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

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