Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 1e5e0f64-301c-4bc2-9607-ea69ce45a7fe
Route
TOPICAL
Published
Effective Date 2023-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naja Naja Venom (0.1 mg) Menthol, (+)- (1 mg) Agkistrodon Piscivorus Venom (0.001 mg)
Inactive Ingredients
Benzalkonium Chloride Glycerin Hypromellose, Unspecified Propylene Glycol Water Sodium Chloride

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2020-09-01 Until 2026-09-30

Description

Cobra venom (Naja naja) 2X 1% (0.1mg)  HPUS                                    Analgesic Menthol (Mentholum) Tinc. 0.1% (1mg)   HPUS                                     Analgesic Moccasin venom (A.piscivorus) 4X 1%(0.001mg) HPUS                           Analgesic Approximately 56 applications per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Purpose

Cobra venom (Naja naja) 2X 1% (0.1mg)  HPUS                                    Analgesic Menthol (Mentholum) Tinc. 0.1% (1mg)   HPUS                                     Analgesic Moccasin venom (A.piscivorus) 4X 1%(0.001mg) HPUS                           Analgesic Approximately 56 applications per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)


Medication Information

Purpose

Cobra venom (Naja naja) 2X 1% (0.1mg)  HPUS                                    Analgesic Menthol (Mentholum) Tinc. 0.1% (1mg)   HPUS                                     Analgesic Moccasin venom (A.piscivorus) 4X 1%(0.001mg) HPUS                           Analgesic Approximately 56 applications per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Description

Cobra venom (Naja naja) 2X 1% (0.1mg)  HPUS                                    Analgesic Menthol (Mentholum) Tinc. 0.1% (1mg)   HPUS                                     Analgesic Moccasin venom (A.piscivorus) 4X 1%(0.001mg) HPUS                           Analgesic Approximately 56 applications per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Warnings:

For external use only.Not for use on open wounds.

• If symptoms persist or worsen, discontinue use, seek medical attention.

• Avoid contact with eyes. If product gets into eyes, flush with water, 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 Center.

• Keep out of reach of children.

Indication:

Temporarily relieves pain associated with arthritis, periodic neuralgia, neck & back pain

Product Label
Directions for Use:
  • Liberally apply gel to affected area and rub into joints.
  • Use 3-4 times per day for the first week. Use as needed thereafter to relieve discomfort.
  • Use no more than 4 times per day.
  • Allow several days for product to take maximum effect.
  • Use within 60 days from opening. Store at 50° to 75°F (10°C to 24°C)
Inactive Ingredients:

Benzalkonium chloride, glycerol, hypromellose, propylene glycol, purified water, sodium chloride.

Active Ingredients                                                                           purpose

Cobra venom (Naja naja) 2X 1% (0.1mg)  HPUS                                    Analgesic

Menthol (Mentholum) Tinc. 0.1% (1mg)   HPUS                                     Analgesic

Moccasin venom (A.piscivorus) 4X 1%(0.001mg) HPUS                           Analgesic

Approximately 56 applications per container

Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)


Structured Label Content

Warnings:

For external use only.Not for use on open wounds.

• If symptoms persist or worsen, discontinue use, seek medical attention.

• Avoid contact with eyes. If product gets into eyes, flush with water, 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 Center.

• Keep out of reach of children.

Indication:

Temporarily relieves pain associated with arthritis, periodic neuralgia, neck & back pain

Product Label (Product label)
Directions for Use: (Directions For Use:)
  • Liberally apply gel to affected area and rub into joints.
  • Use 3-4 times per day for the first week. Use as needed thereafter to relieve discomfort.
  • Use no more than 4 times per day.
  • Allow several days for product to take maximum effect.
  • Use within 60 days from opening. Store at 50° to 75°F (10°C to 24°C)
Inactive Ingredients:

Benzalkonium chloride, glycerol, hypromellose, propylene glycol, purified water, sodium chloride.

Active Ingredients                                                                           purpose (Active Ingredients                                                                           Purpose)

Cobra venom (Naja naja) 2X 1% (0.1mg)  HPUS                                    Analgesic

Menthol (Mentholum) Tinc. 0.1% (1mg)   HPUS                                     Analgesic

Moccasin venom (A.piscivorus) 4X 1%(0.001mg) HPUS                           Analgesic

Approximately 56 applications per container

Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)


Advanced Ingredient Data


Raw Label Data

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