Label: NUDROXICIN PAIN RELIEF ROLL-ON- methyl salicylate, menthol, capsaicin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated February 6, 2018

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  • 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:

    • For external use only. Use only as directed. Avoid contact with eyes and mucous  membranes or genitals.
    • Do not cover or tightly bandage area.
    • on wounds or damaged skin.
    • Do not use with heating pad.

    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

  • INGREDIENTS AND APPEARANCE
    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)
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