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

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PURE EASE Joint & Muscle lnstant pain Relief Cream

Drug Facts

Active Ingredients

Capsaicin 0.025%

Menthol 8.00%

Purpose

Topical Analgesic

Uses:

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:

Label0

PURE EASE JOINT MUSCLE LNSTANT PAIN RELIEF 
capsaicin, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83676-435
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83676-435-0060 mL in 1 JAR; Type 0: Not a Combination Product11/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/27/2023
Labeler - SERENU, INC. (119079642)

Revised: 11/2023
Document Id: 0a063d7f-23a2-c949-e063-6294a90a5b57
Set id: 42bf129c-5c84-4331-b6d0-78e3be71a985
Version: 1
Effective Time: 20231113
 
SERENU, INC.