Label: NITROVAL BLUE- menthol cream

  • 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 June 21, 2022

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  • Drug facts

  • ACTIVE INGREDIENT

    Active ingredients:

    Menthol USP 3.7%

  • PURPOSE

    Purpose

    Topical analgesic

  • INDICATIONS & USAGE

    Uses Temporary relief from minor aches and pains of sore muscles & Joints associated with arthritis, simple backache, strains, bruises & sprains.

  • WARNINGS

    Warnings

    For external use only. Keep away from excessive hear or flame.

  • WHEN USING

    When using this product

    • Avoid contact with the eyes or mucous membranes not apply to wounds or damaged skin.
    • Do not use with other ointments, creams, sprays, or liniments
    • Do not apply to irritated skin or if excessive irritation develops
    • Do not bandaged not use with heating pad or device
    • Wash hands after use with cool water
  • STOP USE

    Stop use and ask a doctor if

    Condition worsens, or if symptoms persist for more than 7 days, or clear up and return.

  • KEEP OUT OF REACH OF CHILDREN

    Warnings
    If pregnant or breast-feeding:     Ask a health professional before use.
    Keep out of reach of children: If accidentally ingested, get medical
    help or contact Poison Control Center immediately.
    Other: Store in a cool dry place. Close cap tightly.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Adults and children 12 years of age and older:
      Apply and massage onto affected areas. Repeat as needed no more
      than 4 times daily. Wash hands after use with cool water.
    • Children under 12 years of age: Consult physician.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Aloe Barbadensis Leaf Extract, Arnica Montana
    Flower Extract, Carbomer, Dimethyl Sulfone (MSM), EDTA, FDC Blue
    #1, ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melaleuca
    Alternifolia (Tea Tree) Leaf Oil, Pyridoxine HCl (Vitamin B6),
    Phenoxyethanol & Methyl/Ethyl/Butyl/Propyl/Isobutyl parabens,
    Polysorbate 20, Purified Water, Tocopheryl (Vitamin E) Acetate,
    Triethanolamine

  • SPL UNCLASSIFIED SECTION

    Manufactured For:
    Plum Valley Pharma, LLC
    Dear born, MI 48120 USA
    Questions and Information please call
    Toll Free: 866-248-1553

  • PRINCIPAL DISPLAY PANEL

    NDC: 82226-160-85                 For Topical Use Only

    NitroValBLUE

    Pain Relief Cream

    Plum
    Valley Pharma

    Net Wt. 3 oz. (85g) Topical Analgesic

    Made in USA

    Manufactured For:
    Plum Valley Pharma, LLC
    Dear born, MI 48120 USA
    Questions and Information please call
    Toll Free: 866-248-1553

    label

  • INGREDIENTS AND APPEARANCE
    NITROVAL BLUE 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82226-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    2-(2-(2-(2-PHENOXYETHOXY)ETHOXY)ETHOXY)ETHANOL (UNII: Y050HYR4XA)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82226-160-8585 g in 1 JAR; Type 0: Not a Combination Product06/21/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/21/2022
    Labeler - PLUM VALLEYPHARMA LLC (118243219)
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