Pure Ease Neur Cream Lnstant Deep Pain Relief

Pure Ease Neur Cream Lnstant Deep Pain Relief
SPL v1
SPL
SPL Set ID e46a4636-6405-440a-a05a-862c354bab54
Route
TOPICAL
Published
Effective Date 2023-11-11
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 Arnica Montana Flower Indian Frankincense Shea Butter Hemp Cetostearyl Alcohol Cetearyl Olivate Cetyl Alcohol Citric Acid Monohydrate Cyanocobalamin Emu Oil Ethylhexylglycerin Glycerin Glyceryl Monostearate 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

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.

Drug Facts

Questions?

302-425-1815

Other Information

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

Package Labeling:

Active Ingredients

Capsaicin 0.025%, Menthol 8.00%

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deioinzed Water), L-Arginine-Monohydrochloride, HCL, Amica Montana FlowerExtract, Ascorbyl Phosphate (Liposomal Vitamin C), Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cannabis Saliva (Hemp) SeedOil, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cyanocobalamin (Vitamin 12), Emu Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Ilex Paraguariensis (Verba Mate') Extract, Magnesium Sulfate, Methyl Salicylate, 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. Rines 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

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.

Drug Facts

Questions?

302-425-1815

Other Information (Other information)

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

Package Labeling:

Active Ingredients

Capsaicin 0.025%, Menthol 8.00%

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deioinzed Water), L-Arginine-Monohydrochloride, HCL, Amica Montana FlowerExtract, Ascorbyl Phosphate (Liposomal Vitamin C), Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cannabis Saliva (Hemp) SeedOil, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cyanocobalamin (Vitamin 12), Emu Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Ilex Paraguariensis (Verba Mate') Extract, Magnesium Sulfate, Methyl Salicylate, 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. Rines 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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