AROMALIEF SOOTHING PAIN RELIEF CREAM SPEARMINT- 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 Spearmint

Active Ingredients

Menthol 1.0% w/w

Topical Analgesic

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

Aromalief Soothing Pain Relief Cream Spearmint 2oz

Aromalief Soothing Pain Relief Cream Spearmint 4oz

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)

Revised: 4/2021
Document Id: c0e16fc8-e820-1e60-e053-2a95a90a3fa7
Set id: c0e1d4f0-d82b-a27d-e053-2995a90a441f
Version: 1
Effective Time: 20210426
 
Marketites LLC