WELLNESS PRODUCTS J-FLEX- capsaicin cream

Wellness Products J-FLEX by

Drug Labeling and Warnings

Wellness Products J-FLEX by is a Otc medication manufactured, distributed, or labeled by Wellness Products, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Wellness Products J-FLEX

Active Ingredient

Capsaicin..................0.07%

Uses

Use for temporary relief of minor aches and pains of muscles and joints associated with:

• Simple backache
  
• Arthritis
• Bruises
• Strains and/ or sprians
  

Warnings

For external use only. Avoid contact with eyes.

Do not apply

to open wounds or damaged skin.  Do not bandage tightly.

If symptoms persist for more than seven days,

discontinue use and consult physician.

Keep out of reach of children

If swallowed, consult physician.

Directions

Apply directly to affected area.  Do not use more than four times a day.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin-C), Carbomer, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Emu Oil, Glucosamine Sulfate, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Polysorbate-20, Sorbitor, Triethanolamine.

Purpose

Pain Relief

PRINCIPAL DISPLAY PANEL

WELLNESS PRODUCTS  

J-FLEX 
Made in U.S.A.  

Arthritis, Muscle and Joint Pain Relief Cream   

NET WT   4 OZ / 118g  

Distributed by:
Wellness Products Corporation
Brooklyn, NY 11224
www.healthcrate.com

Wellness Products J-FLEX 4oz/118g

INGREDIENTS AND APPEARANCE

WELLNESS PRODUCTS J-FLEX 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49671-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.07 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
EMU OIL (UNII: 344821WD61)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITOL (UNII: 506T60A25R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49671-001-04	1 in 1 CARTON	02/10/2017
1		118 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/12/2012

Labeler - Wellness Products (078453111)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(49671-001)