MENTHOL- menthol cream 
Jag Alliance, 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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73143-010-03

ACTIVE INGREDIENT

Menthol  10%

PURPOSE

Topical Analgesic

USES

Aid for temporary local relief of minor pain in muscles or joints.

WARNINGS

IF PREGNANT OR BREAST – FEEDING:

KEEP OUT OF REACH OF CHILDEN:

DIRECTIONS:

Adults and children two-years of age or older:

Additional Information

Store at room temperature.

Inactive ingredients

Aqua, Caprylic/Capric Triglyceride, Alcohol Denat., Stearic Acid, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Helianthus Annuus Seed Oil, Butyrospermum Parkii Butter, Cannabis Sativa Seed Oil, Glycereth-26, Persea Gratissima Oil, Stearyl Alcohol, Sodium Polyacrylate, Aloe Barbadensis Leaf Extract, Glycerin, Boswellia Serrata Extract, Melaleuca Alternifolia Leaf Oil, Mentha Arvensis Herb Oil, Arnica Montana Flower Extract.

PAIN RUB

MENTHOL 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73143-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERETH-26 (UNII: NNE56F2N14)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)  
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE 1000 (UNII: MCU2324216)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73143-010-0396 g in 1 CAN; Type 0: Not a Combination Product07/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/18/2019
Labeler - Jag Alliance, LLC (081456767)
Registrant - Chemco Corporation (032495954)

Revised: 12/2020
Document Id: 663f2b9f-80d7-4aae-82ad-f422876f38a9
Set id: 8de2037b-c6ee-1ba9-e053-2a95a90ab1ef
Version: 25
Effective Time: 20201211
 
Jag Alliance, LLC