Pure Ease Joint & Muscle Lnstant Pain Relief Cream

Pure Ease Joint & Muscle Lnstant Pain Relief Cream
SPL v1
SPL
SPL Set ID 42bf129c-5c84-4331-b6d0-78e3be71a985
Route
TOPICAL
Published
Effective Date 2023-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.25 mg) Menthol (80 mg)
Inactive Ingredients
Allantoin Aloe Vera Leaf Water Arginine Hydrochloride Talinexomer Arnica Montana Flower Magnesium Ascorbyl Phosphate Indian Frankincense Shea Butter Hemp Cannabis Sativa Seed Oil Cetostearyl Alcohol Cetearyl Olivate Cetyl Alcohol Citric Acid Monohydrate Cyanocobalamin Emu Oil Ethylhexylglycerin Glycerin Glyceryl 1-stearate Glycyrrhiza Glabra Helianthus Annuus Flowering Top Magnesium Sulfate, Unspecified Form Methyl Salicylate Dimethyl Sulfone Phenoxyethanol Sorbitan Olivate Stearic Acid Urea Xanthan Gum Corn Ginger

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-27

Description

Capsaicin 0.025% Menthol 8.00%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsaicin 0.025% 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.
  • Provides cooling pain relief.
Warning:

For external use only

Drug Facts

Questions?

302-425-1815

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

Capsaicin 0.025%

Menthol 8.00%

Other Information:

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

Inactive Ingredients:

Allantoin, Aloe Barbadnesis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), L-Arginine-Monohydrochloride, HCL, Amica Montana Flower Extract, Ascorbyl Phosphate (Liposomal Vitamin C), Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cannabis Saliva (Hemp) Seed Oil, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cyanocobalamin (Vitamin B12), Emu Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Ilex Paraquariensis (Verba Mate') Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Phospholipids, Sorbitan Olivate, Stearic Acid, Urea, Xanthan Gum, Zemea (Com) Propanediol, Zingiber Officinalis (Ginger) Extract.

When Using This Product:

Keep out of eyes. Rinse with water to remove

  • 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 Breast Feeding,

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.
  • Provides cooling pain relief.
Purpose

Topical Analgesic

Warning:

For external use only

Drug Facts

Questions?

302-425-1815

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

Capsaicin 0.025%

Menthol 8.00%

Other Information: (Other information:)

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

Inactive Ingredients:

Allantoin, Aloe Barbadnesis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), L-Arginine-Monohydrochloride, HCL, Amica Montana Flower Extract, Ascorbyl Phosphate (Liposomal Vitamin C), Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cannabis Saliva (Hemp) Seed Oil, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cyanocobalamin (Vitamin B12), Emu Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Ilex Paraquariensis (Verba Mate') Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Phospholipids, Sorbitan Olivate, Stearic Acid, Urea, Xanthan Gum, Zemea (Com) Propanediol, Zingiber Officinalis (Ginger) Extract.

When Using This Product: (When using this product:)

Keep out of eyes. Rinse with water to remove

  • 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 Breast Feeding, (If pregnant or breast-feeding,)

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.


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