Label: NO PAIN MORE GAIN- 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 December 16, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Menthol (0.1%) Topical Analgesic

  • PURPOSE

    Use

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    Shake Well. Adults and children of 2 years and older apply to the affected areas up to 4 times a day. Massage in gently.

  • WARNINGS

    Warnings

    For external use only

    Avoid contact with the eyes

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • INDICATIONS & USAGE

    100% Vegan

    No Pain More Gain Cream

    Moisturizing Pain Relief

    NPMG provides temporary but long lasting pain relief and moisturizes the skin. The natural alternative with the advanced German formula starts to work on contact.

    NPMG is

    100% vegan

    gluten-free

    not tested on animals

    made from spring water

    free of paraben, paraffin and silicone oil

    NPMG penetrates deeply, absorbs quickly and has a fresh and pleasant scent.

    Lugus products for the better.

    Manufactured exclusively for

    Lugus Group LLC, Cheyenne, WY 82001

    Manufactured by

    Sowell GmbH 65185 Wiesbaden, Germany

    MADE IN GERMANY

    NET WT 3.4 fl oz (100 ml)

  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, dicaprylyl carbonate, ethylhexyl stearate, glycerin, cetearyl alcohol, prunus amygdalis dulcis (sweet almond) oil, sodium stearoyl glutamate, PPG-3 benzyl ether myristate, panthenol, squalane, xanthan gum, galactoarabinan, citrus medica limonum (lemon) peel oil, phenoxyethanol, benzoic acid, limonene, silica, tocopherol, tetrasodium glutamate diacetate, caprylic/capric triglyceride, ascorbyl palmitate, citric acid, ascorbic acid, sodium hydroxide, penthaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, gold, platinum powder, ethylhexylglycerin, alcohol, dehydroacetic acid, polyaminopropyl biguanide, citral, linalool.

  • PRINCIPAL DISPLAY PANEL

    LAEBL

  • INGREDIENTS AND APPEARANCE
    NO PAIN MORE GAIN 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71618-001
    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
    WATER (UNII: 059QF0KO0R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SQUALANE (UNII: GW89575KF9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GALACTOARABINAN (UNII: SL4SX1O487)  
    LEMON OIL (UNII: I9GRO824LL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    GOLD (UNII: 79Y1949PYO)  
    PLATINUM (UNII: 49DFR088MY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    CITRAL (UNII: T7EU0O9VPP)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71618-001-01100 mg in 1 PACKAGE; Type 0: Not a Combination Product07/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/28/2017
    Labeler - Compes Cosmetic (333032204)
    Establishment
    NameAddressID/FEIBusiness Operations
    Compes Cosmetic333032204manufacture(71618-001)
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