Label: AROMALIEF LIDOCAINE ROLL ON- lidocaine hcl, menthol lotion

  • 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 April 12, 2022

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients

    Lidocaine HCL 4% w/w

    Menthol 1% w/w

  • PURPOSE

    Purpose

    Topical analgesic

    Topical analgesic

  • INDICATIONS & USAGE

    USES For temporary relief of pain.

  • WARNINGS

    Warnings

    For external use only. Avoid contact with eyes.

    Do not use in large quantities, particularly over raw surfaces, or blistered areas.

    Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

    If pregnant or breast feeding, ask a health professional.

  • DOSAGE & ADMINISTRATION

    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.

  • OTHER SAFETY INFORMATION

    Other Information

    store in a cool dry place between (59-86°F) 15-30°C

    don't use if seal over cap is broken, torn or missing

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aloe Barbadensis Leaf Extract, Arnica Extract, Bromelain, C13-14 Isoparaffin, Caprylyl Glycol, Capsicum Annuum Fruit Extract, Chamomile Extract, Devil’s Claw Extract, Dimethicone, Dimethyl Sulfone (MSM), Eucalyptus Oil, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycol Stearate, Horse Chestnut Extract, Isopropyl Myristate, Laureth-7, Lemon Balm Extract, Linden Flower Extract, Menthyl Lactate, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Rosemary Extract, Sweet Almond Oil, Water, Willow Bark Extract

  • QUESTIONS

    Questions or comments

    info@aromalief.com

  • PRINCIPAL DISPLAY PANEL

    Aromalief Lidocaine Pain Relieving Roll On

  • INGREDIENTS AND APPEARANCE
    AROMALIEF LIDOCAINE ROLL ON 
    lidocaine hcl, menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72393-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LEMON BALM OIL (UNII: MJ76269K9S)  
    LINDEN LEAF (UNII: RU6O456OJ1)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SALIX NIGRA BARK (UNII: QU52J3A5B3)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    FRUIT BROMELAIN (UNII: F0ZCA6O9QT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    LAURETH-7 (UNII: Z95S6G8201)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72393-204-2571 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product04/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/06/2022
    Labeler - Marketites LLC (036140212)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!