Simply Vital Pain Relief Hemp Cream

Simply Vital Pain Relief Hemp Cream
SPL v3
SPL
SPL Set ID c14f4c06-cfe5-497e-9f9e-b2ba442e61bb
Route
TOPICAL
Published
Effective Date 2022-07-21
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 2022-08-01

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.

Drug Facts

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 brosken skin.

Questions?:

+1 (205) 624-9177

Active Ingredient

Menthol 8.00%

Package Labeling:

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, Ethylhexylglycerin, 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 a 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.

Drug Facts

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 brosken skin.

Questions?:

+1 (205) 624-9177

Active Ingredient

Menthol 8.00%

Package Labeling:

Other Information: (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, Ethylhexylglycerin, 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 a 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

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