Label: PHARMACY BEST ICE- 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 April 1, 2023

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  • ACTIVE INGREDIENT:

    Menthol, 1.0%

  • PURPOSE

    Topical Analgesic

  • Use

    Pharmacy's Best Ice Gel to provide temporary relief of minor pains and aches in your body's joints and muscles associated with:

    ■ sports injuries ■ sprains ■ arthritis ■ burises

  • WARNINGS:

    For external use only.

    Do not apply to wound or damaged skin. Do not bandage the applied surface. Avoid contact with mucous membranes and eyes.

  • STOP USE

    if condition worsens, discontinue use of this product and consult a physician if symptoms persist for more than 7 days.

  • WHEN USING

    Do not heat in microwave, add to hot water or any container where heating water may cause splattering and result in burns. Do not use with heating devices or pads.

  • KEEP OUT OF REACH OF CHILDREN.

    In case of accidental ingestion, seek professional advice or contact a Posion Control Center immediately.

  • DIRECTIONS:

    For Adults & Children 2 years & older.

    Apply liberally to painful zone and massage until absorbed into the skin. Repeat 3 or 4 times daily. Do not apply to children below two years of age.

  • INACTIVE INGREDIENTS:

    Water (Aqua), Camphor, Ethyl Alcohol, Sodium Hydroxide, Carbomer, Methylchoroisothiazolinone, Methylisothiazolinone, FD&C Blue No. 1.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PHARMACY BEST ICE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58037-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER 934 (UNII: Z135WT9208)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58037-204-01227 g in 1 BOTTLE; Type 0: Not a Combination Product04/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2023
    Labeler - New Pride Corp (884264198)
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