Prfc Hemp Cream Topical Analgesic

Prfc Hemp Cream Topical Analgesic
SPL v2
SPL
SPL Set ID 722da9d1-91d7-45be-adb1-8d6a22aa83ac
Route
TOPICAL
Published
Effective Date 2022-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (80 mg)
Inactive Ingredients
Aloe Vera Leaf Water Cannabis Sativa Seed Oil Cetyl Alcohol Dimethicone Ethylhexylglycerin Isopropyl Alcohol Isopropyl Myristate Polyethylene Glycol 400 Phenoxyethanol Polysorbate 20 Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-07
Description

Menthol 8.00%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Menthol 8.00%

Uses:

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings:

For external use only.

Questions?

+1-775-297-8704

Directions:
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor.
Do Not Use:

on damaged or broken skin.

Package Labeling:

Active Ingredients

Menthol 8.00%

Other Information:

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cannabis Sativa (Hemp) Seed Oil, Cetyl Alcohol, Dimethicone, Ethylhexyglycerin, Isopropyl Alcohol, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-20, Triethanolamine.

When Using This Product
  • Avoid contact with eyes.
  • Do not bandage tightly.
Stop Use and Ask A Doctor If
  • Rash or irritation develops and lasts.
  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
If Pregnant Or Breastfeeding,

ask health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses:

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.

Purpose

Topical Analgesic

Warnings:

For external use only.

Questions?

+1-775-297-8704

Directions:
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor.
Do Not Use: (Do not use:)

on damaged or broken skin.

Package Labeling:

Active Ingredients (Active ingredients)

Menthol 8.00%

Other Information: (Other information:)

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients: (Inactive ingredients:)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cannabis Sativa (Hemp) Seed Oil, Cetyl Alcohol, Dimethicone, Ethylhexyglycerin, Isopropyl Alcohol, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-20, Triethanolamine.

When Using This Product (When using this product)
  • Avoid contact with eyes.
  • Do not bandage tightly.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Rash or irritation develops and lasts.
  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:19.945688 · Updated: 2026-03-14T23:01:49.492831