Dusel Warm Arthritis Dead Sea Salt Therapy (Capsaicin) Cream [Nanovita One Llc] -

DUSEL WARM ARTHRITIS DEAD SEA SALT THERAPY (CAPSAICIN) CREAM [NANOVITA ONE LLC]
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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70656-741-01	5 mL in 1 PACKET; Type 0: Not a Combination Product	04/26/2016

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

Labeler - Nanovita One LLC (080217774)

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