Label: PAIN CRUSH- 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, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient +

    Menthol 7%

  • PURPOSE

    Purpose

    Topical analgesic

  • INDICATIONS & USAGE

    Uses temporarily relieves the minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • on a child under 12 years of age with arthritis-like conditions
  • ASK DOCTOR

    Ask a doctor before use if you have redness over the affected area.

  • WHEN USING

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly or use with a heating pad
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • excessive skin irritation occurs
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • shake well before each use
    • adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store between 20 to 25°C (68 to 77°F)
    • close cap tightly after use
    • see bottom of bottle for Lot No. and Exp. Date.
  • INACTIVE INGREDIENT

    Inactive ingredients

    organic aloe vera leaf juice, organic ethyl alcohol, organic glycerin, organic licorice root extract, organic peppermint oil, purified water (aqua), xanthan gum

  • SPL UNCLASSIFIED SECTION

    +Certified Organic, free of parabens, dyes, petroleum and genetically modified organisms

    Distributed by: Genexa Inc., Beverly Hills, CA 90211 www.genexa.com

    Questions? 1-855-GENEXA-1

    Certified Organic by SCS Global Services

    MADE IN THE USA WITH GLOBALLY SOURCED INGREDIENTS

  • PRINCIPAL DISPLAY PANEL

    Genexa®

    COLD THERAPY PAIN RELIEF ROLL ON

    PAIN CRUSH™

    Menthol / Topical Analgesic

    3 FL OZ (89 mL)

    Back Pain + Arthritis / Sore Muscles + Joints / Shoulder + Leg Pain

    USDA ORGANIC

    NON GMO Project VERIFIED

    FREE OF DYES & PARABENS

    NDC 69676-0004-6

    Pain Crush_label_20190304

  • INGREDIENTS AND APPEARANCE
    PAIN CRUSH 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALCOHOL (UNII: 3K9958V90M)  
    LICORICE (UNII: 61ZBX54883)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0004-689 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product06/13/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/13/2018
    Labeler - Genexa Inc. (079751024)
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