Label: NO PAIN MORE GAIN- menthol 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 December 17, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    Menthol (0.1%)

    Purpose

    Topical Analgesic

  • PURPOSE

    Use

    For temporary relief of muscle and joint pain associated with arthritis, backaches, strains, sports injuries and muscle stiffness

  • WARNINGS

    Warnings

    • For external use only • Avoid contact with the eyes and mucous membranes • Do not use on irritated skin • Do not wrap, bandage, or use a heating pad on the treated area • Do not use on open wounds or broken skin.

  • STOP USE

    Stop use and ask a doctor if

    • Condition worsens • skin irritation occurs • Symptoms persist for more than 7 days or clear up and occur again within a few days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Alcohol , Bambusa Vulgaris Shoot Extract, Benzyl Benzoate, Citral, Citronellol, Geraniol, Glycerin, Hodeum Vulgare Leaf Extract, Hydroxycitronellal, Limonene, Linalool, Parfum, Propylene Glycol, Sodium Polyacrylate, Sorbitol, Vanillyl Butyl Ether, Water, Xanthan Gum

  • INDICATIONS & USAGE

    100% Vegan

    No Pain More Gain

    Roll On

    Moisturizing Pain Relief

    NPMG is • 100% vegan • Gluten-free • Free of paraben, paraffin and silicone oil • Made from spring water • Not tested on animals

    For local noninflammatory pain. No Pain More Gain (NPMG) Roll On provides instant pain relief and moisturizes the skin. The natural alternative with the advanced German formula starts to work on contact and relieves pain for hours. NPMG penetrates deeply, absorbs quickly and has a fresh and pleasant scent.

    NPMG Roll On is a product of

    Lugus Group LLC Buffalo, WY 82834, USA

    NET WT. 1.6 fl oz (50 ml)

  • DOSAGE & ADMINISTRATION

    Directions

    Apply a small amount directly onto the affected area up to four times a day. A hot sensation occurs when NPMG Roll On starts working. If no heat sensation occurs within 6 hours, increase the amount for the next application. Do not use in children under 12 years of age.

  • PRINCIPAL DISPLAY PANEL

    NPMG Roll On

  • INGREDIENTS AND APPEARANCE
    NO PAIN MORE GAIN 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69161-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    BAMBUSA VULGARIS STEM (UNII: SMR633LHTC)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    GERANIOL (UNII: L837108USY)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    LINALOOL, (-)- (UNII: 3U21E3V8I2)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HORDEUM VULGARE TOP (UNII: 86507VZR9K)  
    SORBITOL (UNII: 506T60A25R)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    WATER (UNII: 059QF0KO0R)  
    CITRAL (UNII: T7EU0O9VPP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69161-006-0150 mg in 1 BOTTLE; Type 0: Not a Combination Product10/23/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/23/2017
    Labeler - Lugus Group LLC (079463507)
    Registrant - Lugus Group LLC (079463507)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lugus Group LLC079463507label(69161-006)