Label: AQUACOOL RED 120- 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 June 23, 2016

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  • ACTIVE INGREDIENT

    MENTHOL

  • INACTIVE INGREDIENT

    WATER, GLYCERIN, CABORBER, ACETYL GLUCOSAMINE, IPA, CAMPHOR, METHILPARABEN, KONIO NP-12, RHEODOL O120, EUCALYPTUS OIL, VANILLYL BUTYL ETER, SF1202, LEMON SCENTED TEA TREE OIL, RED102, SODIUM HYDROXIDE, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, LEPTOSPERMUM PETERSONII OIL, ARNICA MONTANA FLOWER EXTRACT

  • PURPOSE

    To relieve pain

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    Apply proper amount to desired area(s) and massage the applied area until it's absorbed to the skin thoroughly.

  • 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 RED 120 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70759-0006
    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
    VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70759-0006-1120 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2016
    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(70759-0006)
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