Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID f1325153-ff95-4a50-920d-d39089829843
Route
TOPICAL
Published
Effective Date 2020-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana Flower (70 mg) Cannabis Sativa Subsp. Sativa Flowering Top (22.33 mg)
Inactive Ingredients
C13-14 Isoparaffin Laureth-7 Polyacrylamide (crosslinked; 0.01-0.2 Mole Percent Bisacrylamide) Water Olive Oil .alpha.-tocopherol Phenoxyethanol Ethylhexylglycerin Edetate Sodium

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-10-28

Description

Arnica (A. montana) Tinc. 7% (70mg)HPUS                                                           Analgesic Hemp extract (Cannabis sativa) 1X 7% (22.33mg) HPUS                                          Anti-inflammatory Approximately 56 applications per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Purpose

Arnica (A. montana) Tinc. 7% (70mg)HPUS                                                           Analgesic Hemp extract (Cannabis sativa) 1X 7% (22.33mg) HPUS                                          Anti-inflammatory Approximately 56 applications per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)


Medication Information

Purpose

Arnica (A. montana) Tinc. 7% (70mg)HPUS                                                           Analgesic Hemp extract (Cannabis sativa) 1X 7% (22.33mg) HPUS                                          Anti-inflammatory Approximately 56 applications per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Description

Arnica (A. montana) Tinc. 7% (70mg)HPUS                                                           Analgesic Hemp extract (Cannabis sativa) 1X 7% (22.33mg) HPUS                                          Anti-inflammatory 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 diagnosed with psychiatric or mood disorder, seek medical advice before use.

• If swallowed, get medical help or contact a Poison Center.

• Keep out of reach of children.

Indication:

Temporarily relieves pain associated with bruises, sore feet, muscle pain and strains

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 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:

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

Comments, Questions Or Complaints?

Call 888-735-4009 or [email protected]

Active Ingredients                                                                                                    Purpose

Arnica (A. montana) Tinc. 7% (70mg)HPUS                                                           Analgesic

Hemp extract (Cannabis sativa) 1X 7% (22.33mg) HPUS                                          Anti-inflammatory

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 diagnosed with psychiatric or mood disorder, seek medical advice before use.

• If swallowed, get medical help or contact a Poison Center.

• Keep out of reach of children.

Indication:

Temporarily relieves pain associated with bruises, sore feet, muscle pain and strains

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 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:

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

Comments, Questions Or Complaints? (Comments, Questions or Complaints?)

Call 888-735-4009 or [email protected]

Active Ingredients                                                                                                    Purpose

Arnica (A. montana) Tinc. 7% (70mg)HPUS                                                           Analgesic

Hemp extract (Cannabis sativa) 1X 7% (22.33mg) HPUS                                          Anti-inflammatory

Approximately 56 applications per container

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


Advanced Ingredient Data


Raw Label Data

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