PURE EASE JOINT MUSCLE LNSTANT PAIN RELIEF- capsaicin, menthol cream

PURE EASE Joint Muscle lnstant Pain Relief by

Drug Labeling and Warnings

PURE EASE Joint Muscle lnstant Pain Relief by is a Otc medication manufactured, distributed, or labeled by SERENU, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Capsaicin 0.025%

Menthol 8.00%

Purpose

Topical Analgesic

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

Do not use:

On damaged or broken skin.

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.

Keep out of reach of children. 

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

If pregnant or breast-feeding,

ask a health professional before use.

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.

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.

Questions?

302-425-1815

Package Labeling:

INGREDIENTS AND APPEARANCE

PURE EASE JOINT MUSCLE LNSTANT PAIN RELIEF 
capsaicin, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83676-435
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
TALINEXOMER (UNII: AZC253V6FB)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
SHEA BUTTER (UNII: K49155WL9Y)
HEMP (UNII: TD1MUT01Q7)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CYANOCOBALAMIN (UNII: P6YC3EG204)
EMU OIL (UNII: 344821WD61)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
METHYL SALICYLATE (UNII: LAV5U5022Y)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARIC ACID (UNII: 4ELV7Z65AP)
UREA (UNII: 8W8T17847W)
XANTHAN GUM (UNII: TTV12P4NEE)
CORN (UNII: 0N8672707O)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83676-435-00	60 mL in 1 JAR; Type 0: Not a Combination Product	11/27/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/27/2023

Labeler - SERENU, INC. (119079642)