NUDROXICIN PAIN RELIEF ROLL-ON- methyl salicylate, menthol, capsaicin liquid 
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 pain relief Roll-On

DRUG FACTS:

ACTIVE INGREDIENTS:

Methyl Salicylate 25.00%
Menthol 6.00% 
Capsaicin 0.025%

Topical Analgesic

USES:

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

WARNINGS:

Do not use

On cuts or infected skin, on children less than 12 years old in large amount.

STOP USE AND ASK A PHYSICIAN:

For severe undiagnosed pain. If pain worsens or persist for more than 7 days. If itching or rash occurs.

Keep out of reach of children.

Consult physician for children under 12.

DIRECTIONS:

Shake before each use. Prior to first use rub small amount to check for sensitivity. Apply product directly to affected area. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Product may be used as necessary, but should not be used more than four times per day.

STORE BELOW (90°F/32°C)

OTHER INGREDIENTS:

Aqua (Deionized Water), Arnica Montana Flower Extract, Beeswax, Boswellia Serrata Extract, Carbomer, Cetearyl Olivate, Ethylhexylglycerin, Glyceryl Stearate, Ilex Paraguayensis (Yerba Mate’) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40B, Sorbitan Olivate, Triethanolamine

Package Labeling:

pdp

NUDROXICIN PAIN RELIEF ROLL-ON 
methyl salicylate, menthol, capsaicin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70859-028
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE250 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL60 mg  in 1 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70859-028-031 in 1 CARTON02/06/2018
190 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/18/2017
Labeler - NuCare Pharmaceuticals Inc (010632300)

Revised: 2/2018
Document Id: 6492c511-c484-c337-e053-2a91aa0a3916
Set id: 6492c511-c483-c337-e053-2a91aa0a3916
Version: 2
Effective Time: 20180206
 
NuCare Pharmaceuticals Inc