Label: THERAFREEZE- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 8, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Menthol USP 6%

  • Purpose

    Pain Reliever

  • Uses

    Temporary relief from minor aches and pains from sore muscles & joints associated with arthritis, backache, strains and sprains.

  • Warnings

    For external use only.

    Flammable: Keep away from excessive heat or open flame.

    Ask a doctor before use if you have: sesnitive skin.

  • When Using This Product:

    • Avoid contact with eyes or mucous membrane.
    • Do not apply to wounds or damaged skin.
    • Do not use with other ointments, creams, sprays or liniments.
    • Do not apply to irritated skin or if excessive irritation develops.
    • Do not bandage tightely.
    • Wash hands after use with cold water.
    • Do not use with a heating pad or device.
  • Stop Use and Ask Doctor if

    • conditions worsen.
    • symptoms persist for more than 7 days.
    • symptoms clear up and occur again within a few days.
  • If pregnant or breastfeeding:

    Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:If accidently ingested, get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 12 years of age and older: Apply on the affacted areas not more than 4 times a day.

    Children under 2 years of age: Consult physician.

  • Other information

    Store in cool dry place.

  • Inactive ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arctum Lappa (Burdock) Root Extract, Arnica Montana Extract, Boswellia Serrata Extract, C13-14 Isoparaffin, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Carbomer-940, Cetearyl Oliviate, Citrus Media Limonum (Essential Lemon) Oil, Ethylhexylglycerin, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Distillate, Helianthus Annuus (Sunflower) seed Oil, IIex Paraguariensis Leaf (Yerba Mate') Extract, Laureth-7, Methylsulfonylmethane (MSM), PEG - 100 Stearate, Phenoxyethanol, Polyacrylmide, Polysorbate - 20, Propylene Glycol, Sorbitan Olivate, Stearic Acid, Tocopheryl Acetate (Vitamin - E), Triethanolamine.

  • Questions or Comments? 1-800-590-3906

  • SPL UNCLASSIFIED SECTION

    For more information,
    please visit our website
    www.astrumpharma.com

    Manufactured in the USA

    No Animal Testing

    Distributed and Marketed by:
    Astrum Pharma, Jersey City,
    NJ-07307

  • Principal Display Panel

    SOOTHING PAIN RELIEF FROM ARTHRITIS, BACK PAIN,
    SORE MUSCLES AND JOINTS

    Cool Therapy Pain Relieving Gel

    THERAFREEZETM

    Vanishing Scent •Natural Menthol •Paraben Free

    NDC # 57329-010-01

    16 FL OZ

    473 ML

    therafreeze Display
  • INGREDIENTS AND APPEARANCE
    THERAFREEZE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57329-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    LAURETH-7 (UNII: Z95S6G8201)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57329-010-01473 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/08/2013
    Labeler - Astrum Pharma (026303692)
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