Label: AQUACOOL MULTI 500- 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 December 20, 2017

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  • ACTIVE INGREDIENT

    MENTHOL

  • INACTIVE INGREDIENT

    Camphor, Carbomer, Eucalyptus Globulus Leaf Oil, Witch Hazel Extract, Arnica Montana Flower Extract, Aloe Barbadensis Leaf Extract, Acetyl Glucosamine, etc.

  • PURPOSE

    External Analgesic: Multi Action Recovery for Warm Up & Cool Down

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    1. Apply gel on to affected areas.

    2. Massage until completely absorbed into skin.

    3. Repeat as many as needed.

    * It is recommended to control the amount and times of use depending on your symptom.

  • DOSAGE & ADMINISTRATION

    for external use only


  • WARNINGS

    Avoid contact with eyes. Stop if irritation occurs. Avoid bandaging tightly. Keep out of reach of children. Ask your doctor before use if pregnant or breast feeding

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    AQUACOOL MULTI 500 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70759-0012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    CAMPHOR, (-)- (UNII: 213N3S8275)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70759-0012-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2017
    Labeler - Pharmanuco (687825097)
    Registrant - Pharmanuco (687825097)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmanuco687825097manufacture(70759-0012)
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