VENODOL- cobra venom anagesic lotion

Venodol by

Drug Labeling and Warnings

Venodol by is a Homeopathic medication manufactured, distributed, or labeled by Caretta Therapeutics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
Cobra Venom (Naja naja) 4x (0.1 mg/gm) HPUS....	Analgesic
(Per Homeopathic Pharmacopoeia of the United States)

INDICATIONS & USAGE

Uses

Temporarily relieves persistent pain associated with inflammation and localized pain associated with strain.

WARNINGS

Warnings

For external use only

• Do not use on broken skin.
• If symptoms persist or worsen, discontinue use and seek medical attention.
• Avoid contact with eyes. If product gets into eyes, flush with water and seek medical attention.
• If an allergic reaction occurs, discontinue use and seek medical attention.
• If rash, redness, irritation, or itching occurs, discontinue use.
• If pregnant or breastfeeding, ask a health professional before use.
• If swallowed, get medical help or contact a Poison Control Center right away.

• Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

• Apply liberally on affected areas.
• Rub thoroughly until fully absorbed.
• Use 3 to 4 times per day. Allow at least two weeks for full effect.
• Use as needed when pain relief is achieved.

SPL UNCLASSIFIED SECTION

Other Information

• This product is NOT intended to treat disease.
• This product is not effective for relieving osteoarthritis pain.

INACTIVE INGREDIENT

Inactive Ingredients

Benzalkonium Chloride, Glycerol, Methocel, Propylene Glycol, Sodium Chloride

QUESTIONS

Questions or Comments?

Call 877-323-9184 toll-free M-F 9:00am to 5:00pm CT.

INFORMATION FOR PATIENTS

Venodol™
ROLL-ON

CONSUMER INFORMATION

FREQUENTLY ASKED QUESTIONS

What is Venodol?

Venodol is an anti-inflammatory, non-opioid, non-steroidal, non-addictive analgesic derived from cobra venom. Venodol does not contain other non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, naproxen sodium or ibuprofen, and does not contain acetaminophen. Venodol is specifically intended for the relief of moderate to severe chronic pain.

What is HPUS?

HPUS is the acronym for the Homeopathic Pharmacopoeia of the United States. Per the HPUS, Venodol's active ingredient, cobra venom, is an analgesic.

Is Venodol addictive?

No. Venodol is not addictive as it is not an opiate-based medication.

Can I overdose from Venodol?

No. Venodol is non-toxic, so overdosing is not a possibility if used as directed.

Are there side effects with Venodol?

Few side effects have been reported but may include headache, localized itchiness or mild rash.

Can Venodol be used with other analgesic medications?

Yes. In clinical use, the active ingredient in Venodol showed no contraindications with any other analgesic products.

CLINICAL HISTORY OF COBRA VENOM

In the Homeopathic Pharmacopoeia of the United States (HPUS) the active ingredient in Venodol, cobra venom (Naja), is recognized in Clarke's Dictionary of Practical Mateira Medica principally as an analgesic.

The venom from a variety of common cobras in Asia (Naja naja or Naja tripudians) has been reported to be effective in standard animal models of pain and inflammation.

Numerous clinical studies with these venoms have reported relief of chronic pain in subjects with a spectrum of persistent conditions.

DIRECTIONS FOR USE

• Use 3 to 4 times per day. Allow at least two weeks for full effect
• Apply liberally on affected areas
• Rub thoroughly until fully absorbed
• Use as-needed when pain relief is achieved

ACTIVE INGREDIENT

Cobra Venom (Naja naja) 4x (0.1 mg/gm) HPUS

INACTIVE INGREDIENTS

Benzalkonium Chloride, Glycerol, Methocel, Propylene Glycol, Sodium Chloride

USES

Temporarily relieves persistent pain associated with inflammation and localized pain associated with strain.

WARNINGS

For External Use Only

• Do not use on broken skin.
• If symptoms persist or worsen, discontinue use and seek medical attention.
• Avoid contact with eyes. If product gets into eyes, flush with water and seek medical attention.
• If an allergic reaction occurs, discontinue use and seek medical attention.
• If rash, redness, irritation, or itching occurs, discontinue use.
• If pregnant or breastfeeding, ask a health professional before use.
• If swallowed, get medical help or contact a Poison Control Center right away.
• Keep out of reach of children.

STORAGE

Store at 50° to 80°F (10°C to 26°C). Use within 90 days of opening.

OTHER INFORMATION

• This product is NOT intended to treat disease.
• This product is not effective for relieving osteoarthritis pain.

WHAT IS CHRONIC PAIN?

Chronic pain is any pain lasting for more than 12 weeks. Chronic pain may result from an initial injury, but people can suffer from chronic pain without any past injuries, traumas or illness. Chronic pain can lead to other health problems, including loss of appetite, fatigue, sleep disturbance, and mood changes.

WHAT SHOULD I EXPECT WHEN TAKING VENODOL?

Venodol builds up in your system over time so it may take up to two weeks for your body to feel the full effect and, therefore, it is important that the product be used as directed to maximize the potential for achieving pain relief. Your response time to Venodol will vary depending on the severity and nature of your pain. Once pain relief is achieved, the application frequency can be adjusted to an as-needed basis. Venodol is not suitable for the relief of acute (sudden onset) pain.

QUESTIONS OR COMMENTS?

Call 877-323-9184 or visit www.venodol.com

Manufactured for Caretta Therapeutics, LLC, 11147 Aurora Avenue, Urbandale, IA 50322

PRINCIPAL DISPLAY PANEL - NDC:

71181-100-02 - Roll-On Bottle Label

PRINCIPAL DISPLAY PANEL - NDC:

71181-100-02 - Roll-On Box Label

INGREDIENTS AND APPEARANCE

VENODOL 
cobra venom anagesic lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71181-100
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	4 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)	0.0001 g  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.2 mL  in 1 mL
HYPROMELLOSES (UNII: 3NXW29V3WO)	0.01 g  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.2 mL  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	0.001 g  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71181-100-02	1 in 1 BOX	06/30/2017
1		56.7 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		06/30/2017

Labeler - Caretta Therapeutics (080471960)