AROMALIEF LIDOCAINE ROLL ON- lidocaine hcl, menthol lotion 
Marketites LLC

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.

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Aromalief LidoHCL

Active Ingredients

Lidocaine HCL 4% w/w

Menthol 1% w/w

Purpose

Topical analgesic

Topical analgesic

USES For temporary relief of pain.

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.

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 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 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 or comments

info@aromalief.com

Aromalief Lidocaine Pain Relieving Roll On

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)

Revised: 4/2022
Document Id: dc7a2254-dd03-d0a2-e053-2a95a90a65ea
Set id: dc01c0fe-12a7-5e28-e053-2a95a90a20e2
Version: 2
Effective Time: 20220412
 
Marketites LLC