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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Asian Cobra venom 280 mcg/mL
Available from:
RECEPTOPHARM INC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses: Temporarily relieves pain associated with sore back, inflamed joints, migraines, painful menses, and general presistent pain
Authorization status:
unapproved homeopathic
Authorization number:
47219-251-10

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.

----------

DRUG FACTS

Active Ingredients

Asian Cobra venom 280 mcg/mL

Purpos e

Analgesic

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

and general presistent pain

Warnings :

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

phys ician.

Inactive Ingredients:

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

Package Label - Principal Display Panel – 1.0 oz Spray Label

According to the Homeopathic Pharmacopeia of the United States

Side effects may include headahce, nausea, sore throat, allergic rhinitis and gastointestinal 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.

Package Label - Principal Display Panel – 1.0 oz Spray Carton

NYLOXIN STAGE 3 PAIN RELIEF

naja naja venom spray, metered

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:47219 -251

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NAJA NAJA VENO M (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM)

NAJA NAJA VENOM 28 0 ug in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

RECEPTOPHARM INC

ANHYDRO US TRISO DIUM CITRATE (UNII: RS7A450 LGA)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

XYLITO L (UNII: VCQ0 0 6 KQ1E)

2 -( DIETHYLAMINO ) ETHANO L (UNII: S6 DL4M0 53U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:47219 -251-10

1 in 1 BOX

1

30 mL in 1 BOTTLE, SPRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Unappro ved ho meo pathic

0 8 /25/20 0 9

Labeler -

RECEPT OPHARM INC (145377888)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

RECEPTOPHARM INC

1453778 8 8

ANALYSIS, MANUFACTURE, API MANUFACTURE

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LIQUID PACKAGING RESOURCES

0 18 9 3516 5

MANUFACTURE

Revised: 11/2009

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