JOINT PAIN FORMULA: Homeopathic Product Information

JOINT PAIN FORMULA- levomenthol and cannabis sativa subsp. sativa flowering top lotion
PROTEGE’ MEDIA LLC

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 Purpose

Hemp extract (Cannabis sativa) 1X 7%(15.7mg) HPUS Anti-inflammatory
Menthol (Mentholum) Tinc. 1% (10mg) HPUS Analgesic

Approximately 56 applications per container

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

Indication:

Temporarily relieves pain associated with arthritis, joint pain and muscle cramps

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.

Directions For Use:

  • Liberally apply lotion 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)

Other Information:

• Consult a medical professional if using other medications for known interactions.
• Cannabidiol in hemp extract may alter the metabolism of other drugs.

Inactive Ingredients:

Ethylglycerin, C13-14 isoparaffin, laureth-7, phenoxyethanol, polyacrylamide, purified water, tetrasodium EDTA, virgin olive oil, vitamin E

Comments, Questions or Complaints?

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PRODUCT IMAGE

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JOINT PAIN FORMULA
hemp extract (cannabis sativa) 1x, menthol (mentholum) tinc. lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76524-342
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL 10 mg in 1 mL
CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP (CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP) CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP 15.7 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
C13-14 ISOPARAFFIN
LAURETH-7
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE)
OLIVE OIL
.ALPHA.-TOCOPHEROL
WATER
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
EDETATE SODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76524-342-02 56 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 10/29/2020
Labeler — PROTEGE’ MEDIA LLC (117063923)

Revised: 01/2021 PROTEGE’ MEDIA LLC

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