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
- 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
- PURPOSE
- INDICATIONS & USAGE
- Warnings
- Directions
- Ohter Information
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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
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INGREDIENTS AND APPEARANCE
AROMALIEF SOOTHING PAIN RELIEF CREAM SPEARMINT
menthol lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72393-306 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:72393-306-04 0.14 g in 1 TUBE; Type 0: Not a Combination Product 03/01/2021 2 NDC:72393-306-02 0.07 g in 1 TUBE; Type 0: Not a Combination Product 03/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2021 Labeler - Marketites LLC (036140212)