NUDROXICIN- menthol, capsaicin patch

NuDroxicin by

Drug Labeling and Warnings

NuDroxicin by is a Otc medication manufactured, distributed, or labeled by NuCare Pharmaceuticals, Inc., Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

ACTIVE INGREDIENTS:

Menthol 5.00%

Capsaicin 0.0375%

Analgesic/Counterirritant

External Analgesic

USES:

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

WARNING:

• For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
• Do not cover with bandage.

Do not use 

• on wounds or damaged skin
• Do not use in combination with and other external analgesic products.
• Avoid contact with eyes and mucous membranes.
• Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.

Keep out of reach of children.

• Consult physician for children under 12.
• Do not use if you are allergic to Menthol.

Stop use and ask a doctor if

• conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days.
• or Rash, itching or excessive skin irritation occurs.

DIRECTIONS:

• Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily.
• Children under 12 years, consult physician before use.
• How to apply:
• Clean and dry affected area
• Cut open pouch and remove patch
• Remove protective film and apply directly to area of pain
• Apply to affected area not more than 3 times daily
• wash hands with soap after applying patch
• Reseal pouch containing unused patched

OTHER INGREDIENTS

Water, Glycerine, Sodium Polyacrylate, Polysorbate 80, Aloe Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt, Diazolidinyl Urea, Methylparaben, Iodoproynyl Butylcabamate, Propylparaben.

Package Labeling:

INGREDIENTS AND APPEARANCE

NUDROXICIN 
menthol, capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70859-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.375 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70859-022-15	15 in 1 CARTON	08/16/2017
1		10 g in 1 PATCH; 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	08/16/2017

Labeler - NuCare Pharmaceuticals, Inc. (010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals, Inc.		010632300	repack(70859-022) , relabel(70859-022)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(70859-022)