Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 196ffa5d-4c1f-4046-91a2-867213a379be
Route
TOPICAL
Published
Effective Date 2023-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (10 mg) Cannabis Sativa Subsp. Sativa Flowering Top (15.7 mg)
Inactive Ingredients
C13-14 Isoparaffin Laureth-7 Polyacrylamide (crosslinked; 0.01-0.2 Mole Percent Bisacrylamide) Olive Oil .alpha.-tocopherol Water Phenoxyethanol Ethylhexylglycerin Edetate Sodium

Identifiers & Packaging

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

Description

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)

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)


Medication Information

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)

Description

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)

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, joint pain and muscle cramps

Product Label
Other Information:

• Consult a medical professional if using other medications for known interactions.

• Cannabidiol in hemp extract may alter the metabolism of other drugs.

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)
Inactive Ingredients:

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

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)


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, joint pain and muscle cramps

Product Label (Product label)
Other Information:

• Consult a medical professional if using other medications for known interactions.

• Cannabidiol in hemp extract may alter the metabolism of other drugs.

Directions for Use: (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)
Inactive Ingredients:

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

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)


Advanced Ingredient Data


Raw Label Data

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