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NDC 70656-0742-01 Dusel Warm Arthritis Dead Sea Salt Therapy 0.25 mg/g Details

Dusel Warm Arthritis Dead Sea Salt Therapy 0.25 mg/g

Dusel Warm Arthritis Dead Sea Salt Therapy is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Nanovita One LLC. The primary component is CAPSAICIN.

MedlinePlus Drug Summary

Topical capsaicin is used to relieve minor pain in muscles and joints caused by arthritis, backaches, muscle strains, bruises, cramps, and sprains. Capsaicin is a substance that is found in chili peppers. It works by affecting nerve cells in the skin that are associated with pain, which results in decreased activity of these nerve cells and a reduced sense of pain.

Related Packages: 70656-0742-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Capsaicin Topical

Product Information

NDC	70656-0742
Product ID	70656-742_48a7a01e-3447-45bf-e054-00144ff88e88
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Dusel Warm Arthritis Dead Sea Salt Therapy
Proprietary Name Suffix	n/a
Non-Proprietary Name	CAPSAICIN
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	0.25
Active Ingredient Units	mg/g
Substance Name	CAPSAICIN
Labeler Name	Nanovita One LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 70656-0742-01 (70656074201)

Pricing Information	N/A
NDC Package Code	70656-742-01
Billing NDC	70656074201
Package	113 g in 1 JAR (70656-742-01)
Marketing Start Date	2016-04-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 85fe0715-cc17-4676-87cf-2164235745d6 Details

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

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

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:70656-742-01	113 g in 1 JAR; 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)

Revised: 2/2017

Document Id: 48a7a01e-3447-45bf-e054-00144ff88e88

Set id: 85fe0715-cc17-4676-87cf-2164235745d6

Version: 3

Effective Time: 20170216