Label: ICY FREEZE- menthol gel

  • NDC Code(s): 66902-165-03, 66902-165-04
  • Packager: NATURAL ESSENTIALS, INC.
  • 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 1, 2017

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  • SPL UNCLASSIFIED SECTION

    ICY FREEZE COOLING PAIN RELIEF

    Drug Facts

  • Active ingredient

    Menthol 3.5%

  • Purpose

    Cooling Pain Relief

  • Uses

    Temporary relief from minor aches and pains associated with:

    • Tendonitis
    • Strains
    • Sprains
    • Sore muscles
    • Joint discomfort
    • Arthritis
  • Warnings

    • For external use only
    • Flammable
    • Keep away from excessive heat or open flame

    Do not use

    • With heating pad or device
    • With creams, ointments, sprays or liniments
    • On wounds, damaged skin or irritated skin

    Ask a doctor before use if you

    • Have sensitive skin
    • Are pregnant or breastfeeding

    When using this product

    • Avoid contact with eyes or mucous membranes
    • Do not bandage tightly

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms persist for more than 7 days or clear up then reoccur again within a few days
    • Irritation develops

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

    Directions Adults/Children 2 years and older:

    • Apply to the affected area not more than 3 to 4 times daily; Rub into skin until solution vanishes

    Children under 2 years old:

    • Application should be supervised by an adult.

    Other information

    • Replace cap after use
    • Store in a cool, dry place.

    Non-medicinal ingredients Aloe Barbadensis Leaf Extract, Mate (Ilex Paraguariensis) Extract, dl-alpha Tocopheryl acetate, Purified Water, dl-Camphor, Carbomer, Isopropyl alcohol, Methylparaben, Triethanolamine.

    MADE IN USA for Healer Health LLC

    Zionsville, Indiana 46077 TM Reg'd 85140-L

    ICYFREEZE.COM

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - Icy Freeze 3oz Gel Pump

    FREEZES PAIN

    THERAPUTIC PAIN RELIEF

    Greaseless and stain free with Aloe, Vitamin E and Ilex

    NATURAL INGREDIENTS • SOOTHING MENTHOL • VANISHING SCENT

    ICY FREEZE

    COOLING PAIN RELIEF

    FOR TENDONITIS, ARTHRITIS, SPRAINS AND STRAINS

    GEL

    4 FL OZ (120 mL)

    Principal Display Panel - Icy Freeze 3oz Gel Pump
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - Icy Freeze 3oz Roll On

    FREEZES PAIN

    THERAPUTIC PAIN RELIEF

    Greaseless and stain free with Aloe, Vitamin E and Ilex

    NATURAL INGREDIENTS • SOOTHING MENTHOL • VANISHING SCENT

    ICY FREEZE

    COOLING PAIN RELIEF

    FOR TENDONITIS, ARTHRITIS, SPRAINS AND STRAINS

    ROLL-ON

    3 FL OZ (90 mL)

    Principal Display Panel - Icy Freeze 3oz Roll On
  • INGREDIENTS AND APPEARANCE
    ICY FREEZE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-165
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-165-031 in 1 BOTTLE, WITH APPLICATOR12/01/2017
    190 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:66902-165-041 in 1 BOTTLE, PUMP12/01/2017
    2120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2017
    Labeler - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-165)
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