Label: ICY COOL MAXIMUM STRENGTH- 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 August 14, 2014

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Natural Menthol 5.5%

  • Purpose

    Topical Analgesic

  • Uses

    temporarily relieves minor pain associated with:

    • arthritis,
    • simple backache
    • muscle strains
    • sprains
    • bruises
    • cramps
  • Warnings

    For external use only

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin
    • a transient burning sensation may occur upon application but generally disappears in several days.

    Stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    Flammable

    • keep away from fire of flame

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help of contact a Poison Control Center right away.

  • Directions

    Adults and children over 12 years:

    • apply generously to affected area
    • message into painful area until thoroughly absorbed into skin
    • repeat as necessary, but no more than 3 to 4 times daily

    IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

    Children 12 years or younger, ask a doctor

  • Inactive ingredients –

    Aloe Barbadensis Leaf Extract, Carbomer, FD&C Blue #1, Glycerine USP, Ilex Paraguariensis Extract, Isopropyl Alcohol USP, Camphor, Propylene Glycol USP, Methyl Paraben, Purified Water, Silicon Dioxide, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine

  • Principal Display Panel - 3 oz. Roll on Label

    QC Quality Choice

    NDC 63868-632-82

    *Compare to BIOFREEZE®
    Pain Relieving Gel

    Maximum Strength

    Icy CoolTM with aloe

    Pain Relieving Roll-On

    Natural Menthol 5.5% | Topical Analgesic

    Relief From Aches and Pains Associated with Strains, Sprains, Backaches, Bruises and Arthritis

    1 Roll-on 3oz./89mL.

    Principal Display Panel - 3 oz. Roll on Label
  • INGREDIENTS AND APPEARANCE
    ICY COOL   MAXIMUM STRENGTH
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-632
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol55 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-632-8289 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2013
    Labeler - C.D.M.A. Inc. (011920774)
    Registrant - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS INC.947484713MANUFACTURE(63868-632)
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