DUSEL WARM ARTHRITIS DEAD SEA SALT THERAPY- capsaicin cream

Dusel Warm Arthritis Dead Sea Salt Therapy by

Drug Labeling and Warnings

Dusel Warm Arthritis Dead Sea Salt Therapy by is a Otc medication manufactured, distributed, or labeled by Nanovita One LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

Active Ingredient:

Capsaicin 0.025%

Topical Analgesic

Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

Warnings:

For external use only.
Avoid contact with eyes.
If symptoms persist for more than seven days, discontinue use and consult physician

Keep out of reach of children.

If swallowed, consult physician.

Do not apply

to wounds or damaged skin.
Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

Directions:

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
Children under two-years of age: consult a physician.

Additional Information:

Store at room temperature.

Other Ingredients:

Aqua (Deionized Water), Ethylhexylglycerin, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose Isopropyl Myristate, Maris Sal (Dead Sea) Salt, Phenoxyethanol, Polysorbate-20, Sea (Dead) Salt, (Corn) Zemea Propanediol.

Package Labeling:

INGREDIENTS AND APPEARANCE

DUSEL WARM ARTHRITIS DEAD SEA SALT THERAPY 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70656-742
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SEA SALT (UNII: 87GE52P74G)
CORN (UNII: 0N8672707O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70656-742-01	113 g in 1 JAR; Type 0: Not a Combination Product	04/26/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/26/2016

Labeler - Nanovita One LLC (080217774)