NUDROXICIN- menthol, capsaicin patch 
NuCare Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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NuDroxicin

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:

Box

NUDROXICIN 
menthol, capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70859-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.375 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70859-022-1515 in 1 CARTON08/16/201712/31/2018
110 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/16/201712/31/2018
Labeler - NuCare Pharmaceuticals, Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals, Inc.010632300pack(70859-022)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(70859-022)

Revised: 4/2023
Document Id: eca0d0fa-a78e-5075-e053-2995a90a1457
Set id: d4279744-bad7-4553-a873-5413f33f5fae
Version: 5
Effective Time: 20230406
 
NuCare Pharmaceuticals, Inc.