Label: AQUACOOL- menthol spray

  • 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 March 9, 2021

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  • ACTIVE INGREDIENT

    MENTHOL

  • INACTIVE INGREDIENT

    ALCOHOL, WATER, GLYCERIN, EUCALYPTUS GLOBULUS LEAF OIL, GLYCYRRHIZA (LICORICE) ROOT EXTRACT, BOSWELLIA SERRATA GUM EXTRACT, ALLANTOIN

  • PURPOSE

    To relieve pain

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    Spray proper amount to treatment area(s)

  • DOSAGE & ADMINISTRATION

    for external use only


  • WARNINGS

    1. Under normal room conditions, the shelf life is estimated at 2 years.
    2. Recommended Use: Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, arthritis, strains, bruises, sprains.
    3. Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
    4. Rub in thoroughly until gel is absorbed.
    5. Use with caution on sensitive areas.
    6. It is recommended that you do a patch test before applying liberally to the skin.
  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    AQUACOOL 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70759-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70759-0004-1150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/201608/09/2016
    2NDC:70759-0004-2120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/04/2016
    Labeler - Pharmanuco (687825097)
    Registrant - Pharmanuco (687825097)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmanuco687825097manufacture(70759-0004)
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