Label: COOLN HEAT MUSCLE RUB WELL AT WALGREENS- menthol gel

  • 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 February 20, 2018

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  • Active ingredient                    Purpose

    Menthol  2.5%                         Topical Analgesic

  • Uses

    temporarily reliefs minor pain associated with • arthritis • simple backache •strains • bruises

  • PURPOSE

  • WarningsFor external use only

    ​When using this product​

    • use only as directed
    • do not bandage tightly or use use with heating pad
    • avoid contact with eyes or mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin
  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    ​Adults and childern over 12 years:

    • squeeze desired amount of pain relieving gel into painful area until throughly absorbed
    • repeat as necessary, but not more than 4 times daily

    ​Children 12 years or younger:​ ask a doctor

  • Inaction ingredients

    Alcohol Denat.
    Allantoin
    Aloe Barbadensis Leaf Extract
    Carbomer
    DMDM Hydantoin
    Glycerin
    Methylparaben
    Phenoxyethanol
    Propylparaben
    Steareth-2
    Steareth-21
    Triethanolamine
    Water

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    COOLN HEAT MUSCLE RUB  WELL AT WALGREENS
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Allantoin (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    Glycerin (UNII: PDC6A3C0OX)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Steareth-2 (UNII: V56DFE46J5)  
    Steareth-21 (UNII: 53J3F32P58)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7002-031 in 1 CARTON07/11/2016
    189 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/11/2016
    Labeler - Walgreens (008965063)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(0363-7002) , label(0363-7002)
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