Label: AROMALIEF SOOTHING PAIN RELIEF CREAM SPEARMINT- menthol lotion

  • NDC Code(s): 72393-306-02, 72393-306-04
  • Packager: Marketites LLC
  • Category: HUMAN OTC DRUG LABEL

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 April 26, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients

    Menthol 1.0% w/w

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    Use For temporary relief of pain

  • Warnings

    Warnings

    For external use only. Avoid contact with eyes.

    Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days, or new symptoms occur.

    Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breastfeeding, ask a health professional.

  • Directions

    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

  • Ohter Information

    Store in a cool dry place between 68º and 77ºF and relative humidity not exceeding 65%.

    Do not use if seal is broken, torn or missing.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Extract, Water, Stearyl Alcohol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isopropyl Myristate, Glyceryl Stearate, Menthyl Lactate, Glycerin, PEG 100 Stearate, Cannabis Sativa Seed Oil, Ulva lactuca Linnaeus, Fucaceae Fucus Vesiculosus, Sodium Hyaluronate, Spearmint (Mentha Viridis), Maltodextrin, Glucosamine Sulfate, Dimethyl Sulfone (MSM), L-Arginine, Glycol Stearate, Phenoxyethanol, Caprylyl Glycol

  • Questions

    Distributed by Marketites LLC

    Coral Gables, FL 33134

    Made in the USA

    Questions? info@aromalief.com

  • PRINCIPAL DISPLAY PANEL

    Aromalief Soothing Pain Relief Cream Spearmint 2oz

  • PRINCIPAL DISPLAY PANEL

    Aromalief Soothing Pain Relief Cream Spearmint 4oz

  • INGREDIENTS AND APPEARANCE
    AROMALIEF SOOTHING PAIN RELIEF CREAM SPEARMINT 
    menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72393-306
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    WATER (UNII: 059QF0KO0R)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    ULVA LACTUCA (UNII: PHR3P25W6Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ARGININE (UNII: 94ZLA3W45F)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72393-306-040.14 g in 1 TUBE; Type 0: Not a Combination Product03/01/2021
    2NDC:72393-306-020.07 g in 1 TUBE; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2021
    Labeler - Marketites LLC (036140212)