Label: AROMALIEF CALMING PAIN RELIEF CREAM LAVENDER- menthol lotion

  • NDC Code(s): 72393-302-02, 72393-302-04
  • Packager: Marketites LLC
  • 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 January 10, 2023

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  • 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, Helianthus Annuus (Sunflower) Seed Oil, Fragrance, Lavandula Angustifolia (Lavender) Flower Oil, 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 Calming Pain Relief Lavender Aromalief Calming Pain Relief Lavender 4oz

  • INGREDIENTS AND APPEARANCE
    AROMALIEF CALMING PAIN RELIEF CREAM LAVENDER 
    menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72393-302
    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
    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)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    WATER (UNII: 059QF0KO0R)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72393-302-040.14 g in 1 TUBE; Type 0: Not a Combination Product08/01/2020
    2NDC:72393-302-020.07 g in 1 TUBE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2020
    Labeler - Marketites LLC (036140212)
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