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NDC 70656-0744-01 Dusel Cool Arthritis Dead Sea Salt Therapy 50 mg/mL Details

Dusel Cool Arthritis Dead Sea Salt Therapy 50 mg/mL

Dusel Cool 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 MENTHOL.

Product Information

NDC	70656-0744
Product ID	70656-744_48a7a01e-3454-45bf-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 Cool Arthritis Dead Sea Salt Therapy
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	50
Active Ingredient Units	mg/mL
Substance Name	MENTHOL
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 70656-0744-01 (70656074401)

Pricing Information	N/A
NDC Package Code	70656-744-01
Billing NDC	70656074401
Package	5 mL in 1 PACKET (70656-744-01)
Marketing Start Date	2016-04-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 293ff2ff-57e2-4a9f-8614-0dece134c99b Details

Drug Facts:

Active Ingredient:

Menthol 5.00%

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:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Ethylhexylglycerin, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Oil, Ilex Paraguayensis (Yerba Mate’) Extract, C13-14 Isoparaffin, Isopropyl Alcohol, Isopropyl Myristate, Maris Sal (Dead Sea) Salt, Phenoxyethanol, Laureth-7, Polyacrylamide, Stearic Acid.

Package Labeling:

INGREDIENTS AND APPEARANCE

DUSEL COOL ARTHRITIS DEAD SEA SALT THERAPY

menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70656-744
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAURETH-7 (UNII: Z95S6G8201)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70656-744-01	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)

Revised: 2/2017

Document Id: 48a7a01e-3454-45bf-e054-00144ff88e88

Set id: 293ff2ff-57e2-4a9f-8614-0dece134c99b

Version: 3

Effective Time: 20170216