PAIN CRUSH (MENTHOL) GEL [GENEXA INC.]

PAIN CRUSH (MENTHOL) GEL [GENEXA INC.]
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NDC 69676-0004-6
Set ID 6e8dd8bb-7204-34ca-e053-2a91aa0a9ef3
Category HUMAN OTC DRUG LABEL
Packager Genexa Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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